High-stakes regulatory meetings require more than strong data. They require a clear scientific narrative, aligned teams, disciplined preparation, and the ability to respond effectively under pressure.

OHMC Regulatory prepares teams for all types of critical regulatory interactions with strategic intelligence, key message strategy, compelling regulatory presentation development, rigorous Q&A preparation, and expert speaker coaching. We help identify vulnerabilities, strengthen arguments, refine presentation delivery, and prepare teams for challenging questions.

Our FDA Advisory Committee mock panels mirror the audience you will face and include former FDA Advisory Committee members, former FDA staff, and clinical experts.

Key meeting types include

• FDA Advisory Committee meetings
• EMA Oral Explanations
• EMA Scientific Advisory Groups
• End-of-Phase 2 meetings
• Pre-NDA and pre-BLA meetings
• Application orientation meetings

Client testimonial

“Thank you for your support and guidance! We were fortunate to have you as the bedrock on which the team could rely when faced with what was a rather ‘against the odds’ mission. It wasn’t always comfortable, but you helped us to develop more confident, coherent messaging and poise in answering questions.”

Clear, compliant, and scientifically rigorous documentation is essential to regulatory success.

OHMC Regulatory provides end-to-end regulatory medical writing and document development support for pharmaceutical, biotechnology, and healthcare organizations. Our specialized team of writers produce clear, compliant, and scientifically rigorous documents across all development stages.

We integrate seamlessly with your cross-functional team to ensure every document is accurate, consistent, defensible, and aligned with global regulatory expectations. Professional project management and industry-leading quality control help drive your program forward.

Key documents and services include

• Regulatory submission packages
• Briefing documents
• Health Authority response documents
• IND, NDA, MAA, and BLA support
• Clinical study reports
• Protocols
• Investigator brochures
• Risk management plans
• Periodic safety reports
• Benefit-risk narratives
• Regulatory slide decks
• Scientific communication materials

Client testimonial

“Thank you for the incredible support you have provided as a team, 
it underpins much of our success this year as a company.”

Regulatory questions can determine the direction, tone, and outcome of key Health Authority interactions.

OHMC Regulatory provides a systematic approach to Health Authority Q&A preparation through coordinated strategy development, structured content creation, and rigorous internal validation. The program establishes an evidence-based framework for addressing Health Authority inquiries.

Our goal is to help teams be prepared to develop rapid responses with clarity, consistency, 
and confidence.

Support includes

• Q&A strategy workshops
• Anticipated question development
• Challenge panels
• Internal validation sessions
• Rapid response writing

Client testimonial

“The team is meeting with China [Regulatory] next week, 
the work done has been the foundation for these discussions.”

“We had only two days to respond to Japanese HA, 
and we already had our answers because of this program.”

Successful regulatory interactions depend on more than the data; they depend on how the evidence is framed, prioritized, and communicated.

From strategy and messaging workshops to cross-functional team coaching, OHMC Regulatory aligns with your organization on your regulatory pathway and key messages that will guide interactions with the FDA, EMA, and other Health Authorities.

Through strategy workshops, messaging sessions, storyboard development, and cross-functional coaching, we help teams build a communication platform that is clear, credible, and defensible. We help your organization understand the audience, anticipate scrutiny, and communicate your regulatory story with purpose.

Support includes

• Regulatory communications strategy
• Target product profiles/label optimization
• Scientific messaging workshops
• Storyboard development
• Benefit-risk narrative development

Client testimonial

“Your help and strategic guidance were invaluable. There is no way we could have been ready without you. Thank you, thank you, thank you!!!”

Effective regulatory preparation requires disciplined planning, strong facilitation, and clear decision-making.

Based on 30 years of experience refining best practices, our team carefully plans, manages, and facilitates effective meetings designed to drive consensus, leverage critical feedback, advance your strategy, and keep you on a trajectory of continuous progress.

Typical meeting types include

• Strategy and messaging workshops
• Mock FDA Advisory Committee meetings
• Q&A rehearsals
• Working sessions

Support Includes

• Agenda and content development
• Participant recruitment 
and management
• Meeting facilitation/moderation
• Timeline and milestone management
• Action tracking and follow-up
• Logistics and meeting management

Client testimonial

“I want to thank you for the great workshop yesterday and today. The team is completely energized and excited and that is – to a great extent – because 
of your work! Everybody was impressed with your leadership and expertise, and we feel confident that together we can make this happen!”

Regulatory interactions require speakers who can communicate complex science clearly, respond to difficult questions, and maintain confidence under pressure.

Our dynamic speaker coaching helps your team communicate with confidence—whether presenting complex data, leading cross-functional meetings, or navigating regulatory negotiations.

Our coaching combines expert instruction, real-world regulatory scenarios, hands-on exercises, presentation refinement, and Q&A practice to build lasting communication skills.

We help scientific and executive teams communicate with precision, credibility, and impact.

Support includes

• Presentation coaching
• Q&A response training
• Executive coaching
• Scientific storytelling workshops
• Meeting facilitation workshops
• Medical science liaison training
• Speaker bureau keynotes 
and workshops

Client testimonial

“We could not have done it without you! Thank you for your patience, support, planning, creativity and, most important, coaching.”

Navigating regulatory pathways requires more than data and technology—it requires human judgment shaped by deep FDA and regulatory experience.

OHMC Regulatory combines expert guidance with strategic technology to help your team succeed with Health Authorities.

Supported by secure, intelligent collaboration tools:

• OmniAI and Omnicom’s enterprise-grade infrastructure enable seamless teamwork while maintaining data integrity and security
• Intuitive platforms support efficient collaboration across remote, in-person, and global teams
• SRS: our proprietary presentation system provides seamless slide retrieval and projection with in-house management and AV support
• Compelling slide design and 
data visualization

The difference? While technology enables efficiency, human expertise drives influence. Our humans-in-the-loop approach ensures that we bring our years of experience in regulatory strategy, medical writing, and Health Authority interactions to every engagement.

Client testimonial

“Your guidance, slide retrieval system, and support were instrumental in the feeling of confidence I had during both the presentation and the question/answer period.”