Deep Dive into Regulatory Solutions at DIA RSIDM 2025

Deep Dive into Regulatory Solutions at DIA RSIDM 2025

This February, DIA RSIDM 2025 returns to Bethesda, MD, reaffirming its reputation as the premier event for regulatory professionals to exchange the best solutions for managing complex regulatory submissions. At fme, we specialize in helping pharmaceutical and biotechnology companies navigate regulatory challenges with expertise in selecting, planning, and migrating to RIM solutions tailored to their unique data, documents, and workflows. Visit us at Booth #315 during the RSIDM forum—we’d love to discuss your challenges and plans for 2025!

Operational Efficiency is Critical

Every day, pharmaceutical companies strive to demonstrate the efficacy of new discoveries and deliver life-changing medications to patients in need. To accelerate time-to-market and ensure safety, timely and high-quality regulatory submissions to health authorities are critical for review and approval.

However, the process is fraught with challenges. The sheer volume and complexity of data, documents, and information exchanged among multiple stakeholders and systems create significant hurdles in maintaining accurate, up-to-date documentation. Errors, omissions, or inconsistencies can lead to costly delays and disrupt expected release timelines.

Seasoned regulatory professionals recognize the importance of operational efficiency in managing regulatory information effectively throughout the development cycle, ensuring smooth and successful submissions.

Keys to RSIDM Efficiency and Success

Efficiency and success in regulatory operations depend on seamlessly aligning people, processes, and technology throughout a medication’s journey—from conception to patient use. With years of experience and a proven track record, fme has gained deep insights into the complexities of every phase of this journey. This expertise has enabled us to develop and refine methodologies that:

  • Analyze existing systems and workflows
  • Align requirements with tailored technology solutions
  • Ensure data and documents are accurately classified for discovery and use

fme’s experts combine a deep understanding of the product development lifecycle with extensive experience in regulatory projects. Staying ahead of evolving data standards, requirements, and technology trends, we guide clients toward the best solutions for today while future-proofing their decisions to deliver long-term ROI.

Download this overview to see how fme can help you achieve regulatory excellence and why we are recognized as a leader in content management solutions for regulatory environments.

Connect with fme at DIA RSIDM 2025

Last year, fme’s David Gwyn spoke on “Leveraging Structured Content Authoring in Regulatory Submissions: Real-World Experience, Industry Insights and Tools.” This presentation focused on the latest EDM Structured Reference Model team developments, showcasing how their work influences industry-wide adoption. For more information, view the full details of the session here.

For 2025, David will be joined by RIM experts Jonathan Byars and Frank D’Entrone to provide their expertise on effective strategies to align people, processes, and technology for RIM success. fme’s experience across platforms, industries, and global territories gives us unparalleled insights into the best strategies and solutions and how to ensure a successful journey to regulatory excellence.

What are your challenges for 2025? Use the form below to request a no-cost discovery session and we’ll schedule a time to discuss your concerns and possible solutions. If you are attending RSIDM 2025, join us at Booth #315 and we can start the conversation in person! If you can’t attend this year, download the overview and let us know if you’d like to talk.

The DIA RSIDM 2025 Educational Tracks

The educational tracks for this year’s conference reflect the continued integrated communication challenges regulatory professionals face within a quickly evolving technology landscape. Download the overview above to learn more about how we can support your team in each.

  • Track 1: Building and Sustaining Successful RSIDM Foundations
    • This track is designed for attendees who are either new to the field or seek a comprehensive review of the evolving dynamics and intricacies that shape their day-to-day work.
  • Track 2: Optimizing Processes and Procedures
    • This track is tailored for intermediate-level professionals and focuses on what is needed to improve processes, procedures, and data to foster a culture of innovative practices and forward-thinking. Learn proven industry best practices and discuss the impact of new global regulations on your organization’s processes and procedures.
  • Track 3: Adopting Innovative Technologies
    • This intermediate to advanced track provides first-hand knowledge from global regulatory health authorities on the implementation of new technologies, policies, and guidelines. It also includes perspectives on how to incorporate technology advancements like artificial intelligence and automation, and how to assess their effectiveness and impact.
  • Track 4: Achieving Regulatory Excellence
    • This advanced track is designed for leadership roles, and includes examples and use cases from organizations that have achieved regulatory excellence. It covers a wide range of practical implementation strategies to support vision, cultural change, and commitment to innovation.

We are excited to participate in these valuable conversations with regulatory thought leaders and re-connect with industry colleagues! Find the full RSIDM 2025 agenda here, and contact us if you have any questions about the specific tracks or sessions offered. We look forward to seeing you there!

Join fme in Boston at the Veeva Summit: R&D and Quality

Join fme in Boston at the Veeva Summit: R&D and Quality

The 2024 Veeva Summit: R&D and Quality is in Boston in a few weeks and fme is honored to be one of the few certified partners to have been selected as a Gold sponsor. We look forward to sharing our experience and strategies with the Veeva community again this year. We cordially invite you to join us to network, share strategies and learn more about the capabilities of the Veeva platform.

Veeva Summit

With over 2,000 life science industry professionals attending, the Veeva Summit in Boston is the best place to get first-hand details on today’s most effective R&D and Quality strategies and solutions for content management. fme is a certified partner supporting the Veeva platform for Life Sciences firms through selection, migration and maintenance, so we’ll be sharing our proven methodologies to best configure, utilize, and support this powerful platform and leverage its capabilities to achieve business goals.

Each year, the Veeva Summit deliver unique value to attendees:

  • Gain insights into the latest features and enhancements within Veeva’s powerful platform, and how it can help you achieve your business goals.
  • Understand how fme can help plan and optimize your Veeva environment, ensuring seamless integration, operation, and maximum ROI.
  • Exchange ideas, network, and learn from industry professionals to help you stay ahead of industry trends and competition.

Why Migrate to Veeva Vault?

Throughout the Veeva Summit, clients and partners will be sharing their knowledge and strategies for planning, integrating, utilizing and maintaining the platform. Veeva Vault offers a unified suite of applications designed to manage the critical content and data in life sciences. By centralizing information across quality, regulatory, and clinical operations, Veeva Vault enhances collaboration, improves compliance, and accelerates time to market. However, the migration to such a robust system is not without its challenges. Moving large volumes of data from legacy systems, databases, and various content repositories requires expertise, precision, and a deep understanding of the unique needs of the life sciences industry.

fme at Veeva Summit

With decades of experience in the life sciences sector, fme has established itself as a leader in data and document migration services and is your trusted partner for Veeva Vault migrations. Drawing on my personal experience in migrating legacy data and documents, I understand firsthand the challenges clients face—from navigating complex regulatory requirements to ensuring data accuracy and integrity throughout the migration process. This insight drives our commitment to making your migration to Veeva Vault as seamless as possible.

Industry Expertise That Sets Us Apart

At fme, we bring extensive experience in the life sciences industry to every migration project. Having personally worked on numerous migrations, I know fme’s expert team understands the intricate challenges that come with moving critical data and documents. Our team have extensive knowledge of the stringent regulatory requirements that govern the industry, including GxP compliance, and we ensure that every step of the migration process meets these standards. Our expertise spans quality management, regulatory affairs, and clinical operations, making us uniquely qualified to handle the nuanced needs of your migration to Veeva Vault.

Comprehensive Migration Services

Our migration services are comprehensive, covering every phase of the migration journey. We start by thoroughly assessing your existing systems and data to understand the migration scope and identify potential challenges. Leveraging our many years of migration experience, we collaborate with you to create a migration plan that aligns with your business objectives and addresses concerns upfront. We then meticulously map your data to the Veeva Vault structure, ensuring all necessary transformations are applied for accuracy and readiness. Utilizing our specialized tool, migration-center, we handle the extraction, transformation, and loading of data from various source systems into Veeva Vault, with rigorous validation processes to meet all regulatory requirements. Post-migration, we provide ongoing support to ensure your Veeva Vault environment functions smoothly, offering training, troubleshooting, and customization as needed, backed by my experience in anticipating and resolving issues.

migration-center: The Power Behind Our Migrations.

migration-center, our purpose-built migration tool, is designed to simplify even the most complex migrations. Capable of supporting over 250 source-to-target system combinations, migration-center seamlessly handles content extraction and migration to Veeva Vault from databases, file shares, cloud platforms, and legacy applications. This flexibility ensures that no matter where your data currently resides, we can migrate it efficiently and accurately to Veeva Vault.

Tailored Solutions for Unique Needs

We understand that every organization is different, with unique challenges and requirements. That’s why we don’t take a one-size-fits-all approach. Having personally navigated various migration scenarios, I know how important it is to tailor our services to meet your specific needs. Whether you’re migrating a small dataset or a complex array of content types, we have the expertise and tools to deliver a solution that works for you.

A Commitment to Compliance and Quality

In the life sciences industry, compliance isn’t optional—it’s essential. We are experts in ensuring that your migration process adheres to the strictest regulatory standards. From GxP compliance to meticulous documentation, we leave nothing to chance. Our team works closely with your quality assurance teams to validate every aspect of the migration, giving you peace of mind that your data is accurate, complete, and ready for regulatory scrutiny.

Why Choose fme for Your Veeva Vault Migration?

Migrating to Veeva Vault is a significant undertaking, but with fme as your partner, it doesn’t have to be daunting. We combine deep industry knowledge, cutting-edge tools, and a client-centric approach to deliver migration services that are seamless, secure, and compliant. My personal experience in the life sciences industry has equipped me with the insights necessary to anticipate challenges and guide you through a successful migration.

Contact Us Today!

Ready to make the move to Veeva Vault? Contact us today to learn how fme can support your migration and help you unlock the full potential of your content management system. We’ll schedule a discovery meeting with our Veeva experts to discuss your current challenges and introduce the range of possibilities and next steps to accelerate your journey to success.

Not Attending Veeva Summit?

Not attending the Veeva Summit in Boston this year? That’s an even better reason to contact us to schedule a personalized presentation. We’ll share the newest updates and announcements from Veeva, and discuss solutions for your short- and long-term challenges.

Join fme in Madrid at the Veeva Summit R&D and Quality

Join fme in Madrid at the Veeva Summit R&D and Quality

Veeva Product Certified Silver Partner Badge
Veeva Migration Certified Badge
Veeva Migration Certified Badge

The 2024 Veeva Summit: R&D and Quality for clients and partners is around the corner, and fme has once again selected as a Gold sponsor. Only a select group of certified partners are invited to participate, and we are honored to be able to share our experience and strategies with the Veeva community. We cordially invite you to join us to explore how we can work together to leverage the power of the Veeva platform to achieve your business goals.

Veeva Summit for European Clients

The Veeva Summit in Madrid is the continent’s best opportunity to learn the crucial R&D and Quality best practices and solutions for content management, as well as network with industry professionals from leading Life Sciences firms. Since fme specializes in providing Life Sciences firms with implementation, integration, and support of Veeva content management solutions, we’ll be sharing our experience on how to best configure, utilize, and support this powerful platform throughout an organization that is ready to leverage the power of advanced technology.

This year’s Veeva Summit promises to deliver unique value to attendees:

  1. Gain insights into the latest features and enhancements within Veeva’s powerful platform, and how they help you reach your IT and business goals.
  2. Understand how fme provides end-to-end solutions to optimize your Veeva environment, ensuring seamless integration, operation, and maximum ROI.
  3. Exchange ideas, network, and learn from industry professionals to help you stay ahead of industry trends and competition.

fme at the Veeva Summit

The Veeva Summit is a valuable learning opportunity. fme’s Life Sciences experts will be answering questions, demonstrating our capabilities, and proving how our experience and innovation can bring your organization to new heights. Here are a few solutions designed to deliver exceptional benefit to our Veeva clients:

  • Migration Planning and Execution – Good content in, good content out – get it right from the beginning. fme’s technical experience, business process knowledge, and proprietary tool migration-center make us an unsurpassed choice to migrate your content into the Veeva platform, consolidate legacy platforms, or migrate data Vault to Vault. Learn more >>
  • fme migration-center – fme’s proprietary migration-center solution can save you 60% in costs and 80% in project duration compared to developing your own scripts and frameworks. Learn more in our migration-center for Veeva datasheet >>
  • fme dqMan Veeva Vault Edition – Based on VQL and MDL, dqMan provides exclusive capabilities and a broad feature set designed to boost productivity and maximize efficiency by eliminating manual, time-consuming tasks. Learn more >>
  • fme HealthCheckAssist – Personalized roadmap to Veeva success. HealthCheckAssist provides an in-depth assessment of your current configurations and usage of your Vault RIM solution, then delivers a detailed report containing recommendations and a clear roadmap to optimize and improve the use and value of the platform. Learn more >>
  • fme PlatformAssist – Keep your Veeva platform delivering top performance and value. PlatformAssist is a comprehensive set of modular building blocks that ensure you are at your best through updates, process flow customizations, and daily support issues post go-live. Learn more >>
  • fme SelectAssist – Life Sciences companies face many challenges when selecting new software solutions and platforms. SelectAssist is designed to gather and consolidate requirements, incorporating the perspective of end users, technology requirements, and business goals. We then evaluate solutions and make recommendations for solutions that will meet complex business requirements and gain widespread user acceptance. SelectAssist simplifies software selection for you. Learn more >>
  • fme MetatdataAssist – Effortless metadata updates. Whether before a migration or within an existing repository, MetadataAssist uses advanced AI and NLP (Natural Language Processing) to reconnect lost documents without the frustration, time, or costs to your key business resources. Quickly and efficiently update your content’s metadata to ensure they are properly classified and discoverable in your Veeva system. Learn more >>

Even if you aren’t attending the Veeva Summit, contact us to schedule a personalized presentation on how fme can provide the end-to-end knowledge and support you need to maximize the value of your information with the Veeva platform.

Contact Us Today!

To learn how fme has earned their place as an end-to-end Veeva partner and to get more details on the conference, contact us today. We’ll schedule a discovery meeting with our Veeva experts to discuss your current challenges and introduce the range of next steps that can accelerate your journey to success.

Solutions for the CARA Platform at Generis Generate 2024

Solutions for the CARA Platform at Generis Generate 2024

fme is excited to be presenting our CARA Platform success stories and solutions at Generate 2024 in Lisbon, Portugal this April. As a certified Generis partner, we’ll be contributing to the discussions and sessions focused on maximizing the value of The CARA Platform and The CARA Life Sciences Platform, specifically built for Life Sciences applications.

Here are a few of the topics we’ll be sharing. Contact us below to schedule a custom presentation on how fme can serve your CARA Platform needs.

Successful Migrations to The CARA Platform

The fme team are experts at migrating data, documents and content into, out of, and within the leading content management platforms in the most complex regulated industries. We bring all our experience and know-how to The CARA Platform and have earned our Certified Partner badge year after year.

Whether you are moving to CARA for the first time, consolidating repositories, or upgrading to the newest release, fme understands the possibilities and pitfalls of the platform, and can ensure you have a smooth transition that delivers the maximum ROI while minimizing downtime. Our business consulting and technology services teams work together to provide end-to-end CARA implementation support to ensure your configuration and integration is effectively aligned with your business processes and goals.

Custom-built Tools and Solutions

fme has built a portfolio of proprietary tools and services to streamline and accelerate migration initiatives that we apply to CARA Platform initiatives. Each of these solutions has been tested, refined, and proven through years of client projects.

migration-center™: Save you 60% in costs and 80% in project duration with migration-center, our proprietary migration tool that is CARA ready, allowing you to minimize risks while migrating from any source system into CARA with ease. Learn more >>

MetadataAssist℠: Leverage the power of guided AI and NLP to identify and rescue disconnected content. MetadataAssist supplements your team’s expertise to accelerate the analysis, identification, categorization, and updating of metadata on millions of documents in a fraction of the time. We ensure all your information is fully organized and accessible. Learn more >>

HealthCheckAssist℠ for Generis: Don’t guess at how to improve – HealthCheckAssist tells you where you are and where you should go next based on your own priorities and business goals. Our experts analyze and evaluate your current system and provide a prioritized roadmap for best next steps to enhance efficiency and effectiveness. Learn more >>

PlatformAssist℠ for Generis: Reduce your platform management costs. PlatformAssist provides in-depth vendor release management, application change management, application and admin support and more for carefree, cost-effective management of your CARA platform. Learn more >>

compliance-center℠: Streamline, simplify, and accelerate your validation workflows. Built on the CARA platform and based on the CSA guidelines plus our 25 years of working with global pharmaceutical firms, compliance-center’s intuitive interface and clear instructions guides you through your validation process, providing detailed direction on when you can take advantage of CSA, when traditional CSV is required, and when a hybrid approach is possible. Learn more >>

Let’s Connect at Generate 2024!

If you are attending Generate, contact us so we can connect at the booth and join us for our VP of Business Consulting David Gwyn’s presentation on Insights and Best Practices for Maximizing the Value of The CARA Platform. We look forward to seeing you there!

Not attending? No Problem!

If you aren’t able to attend Generis Generate this year, we still have you covered! Connect with us below and we’ll send you the conference slides, and schedule a customized introduction to our CARA Platform solutions.

Will we see you at DIA RSIDM 2024?

Will we see you at DIA RSIDM 2024?

Will you be attending DIA RSIDM 2024 in Bethesda, MD in February? This annual event is the premier gathering for professionals working in the pharmaceutical, biotechnology, and regulatory industries, focusing on the critical aspects of submissions, information management, and document compliance.

The importance of operational efficiency across the full process and technology environment that enables the management of regulatory information cannot be understated. It is vital to provide timely, quality regulatory submissions to health authorities in order for drug companies to accelerate the delivery of therapeutics and vaccines to their patients. At DIA’s Regulatory Submissions, Information, and Document Management (RSIDM) Forum, industry and regulatory stakeholders collaborate to examine current and evolving data standards and requirements and effective regulatory information management approaches to align related people, processes, and technology.

If you’ve attended in the past, the 2024 Forum includes a refreshed set of tracks and focus areas that will provide invaluable insights on how to build and sustain successful RSIDM foundations, optimize their current processes and procedures, adopt innovative technologies, and achieve regulatory excellence. You’ll also have ample opportunities for networking, knowledge sharing, and education for both business and technology-focused topics at all levels.

Connect with fme’s David Gwyn at DIA RSIDM 2024

This year, fme’s own VP of Business Consulting David Gwyn will be attending DIA RSIDM @presenting and contributing to the many discussions with industry and regulatory stakeholders covering the effective strategies to align related people, processes, and technology for business success.

Use the contact form below to get connected before the event, or make plans to join his session on February 14:

Leveraging Structured Content Authoring in Regulatory Submissions: Real-World Experience, Industry Insights and Tools
View Session >>
Feb. 14, 8:30am
Bethesda North Marriott Hotel and Conference Center
Brookside (Lower Level)

Other Essential Sessions

If you haven’t reviewed and selected your sessions yet, here are just a few we feel are worth the time to attend. Hope to see you there, and let us know if you have any questions on these topics!

Fostering Trustworthy and Responsible AI
View Session >>
Keynote Address
New and emerging technologies like AI have undeniably proven their potential in optimizing processes, improving decision-making, and enhancing the collection and management of data across the lifecycle. Reggie Townsend, VP of Data Ethics Practice at SAS, will share insights on how AI and other emerging technologies can be responsibly leveraged in regulatory affairs and operations.

The Future of Regulatory Submissions: Innovation of the Possible using a Non-disruptive Framework
View Session >>
Technology may be disruptive and revolutionary but must be introduced in a non-disruptive way to a highly regulated environment. Innovation within the CTD / eCTD v4.0 framework including cloud computing provides exactly this vehicle for change.

Shaping and Overseeing Regulatory Strategy, Operations, and Vendor Relationships
View Session >>
Enable high-quality relationships between clients and vendors in the regulatory submissions space, and successfully shifting from a vendor-based RIM model to an in-house operation. We will also delve into acquisitions and mergers/partnerships as they relate to strategy and execution in submissions operations.

So, You Think Technology Solutions are Failing your Content Transformation? Did You Set Them up for Success?
View Session >>  
The most successful intelligent automation implementation teams think content before software: a software-agnostic mindset is key to success. This session will discuss how applying a software-agnostic methodology can supports effective content transformation across people, processes, technology, and data/content.

We are excited to participate in these valuable conversations with regulatory thought leaders, and re-connect with industry colleagues! Find the full schedule here, and contact us if you have any questions about the specific tracks or sessions offered. We look forward to seeing you there!

Join fme in Boston at the Veeva Summit: R&D and Quality

Join fme in Boston at the Veeva Summit: R&D and Quality

fme has been selected as a Gold Sponsor for the Veeva Summit: R&D and Quality for Boston this September, and we are looking forward to sharing our experience and strategies with the Veeva community. We enjoyed June’s European summit in Madrid, and are honored to be recognized in an elite group of certified partners invited to participate in the North American event.

We’d love for you to join us to explore how to leverage the power of the Veeva platform to achieve your business goals.

Join fme at the Veeva Summit!

fme specializes in the end-to-end implementation, integration, and support of the Veeva platform. At the summit our team of experts will be answering questions, discussing our capabilities, and proving how our partnership can guide organizations to new heights of efficiency and productivity. We will also be highlighting our newest offerings that deliver exceptional benefit to our Veeva clients:

  • fme PlatformAssist™ – A comprehensive set of modular building blocks that provide you with the unique end-to-end services needed for carefree post go-live management of your Veeva platform.
  • dqMan for Veeva Vault – Modeled after our popular dqMan for Documentum, our new version is focused on the specific requirements of Veeva clients, eliminating time-consuming and repetitive tasks and making admin and data management easy.
    If you are attending the summit, contact us and let’s set up a time to meet so you can get the most value from the summit.

If you are attending the summit, contact us and let’s set up a time to meet so you can get the most value while we’re there together.

Contact us to learn more

fme delivers the end-to-end knowledge and support you need to maximize the value of the Veeva platform. We’d love the opportunity to share our experience on how to best configure, utilize, and support Veeva for the unique challenges of your organization.

Contact us to schedule a personalized presentation aligned with your unique challenges. To schedule a discovery meeting with fme’s Veeva experts, reach out to our Global Sales Director René Rosenberg at r.rosenberg@fme-us.com.