Strengthen your agency engagement strategy
The value of health authority engagement depends on choosing the right interaction, asking focused questions, and engaging when your evidence is mature enough to support meaningful feedback.
Cencora combines regulatory strategy, cross-functional content development, meeting preparation, and global coordination to help you identify development risks, clarify expectations, and act on agency advice.
Cencora combines regulatory strategy, cross-functional content development, meeting preparation, and global coordination to help you identify development risks, clarify expectations, and act on agency advice.
Avoid the missteps that can weaken your agency engagement
Health authority engagement rewards preparation and exposes gaps in execution. With regulatory strategy and program management across regions, Cencora helps you address the pressures that most affect outcomes.
Global coordination
Programs increasingly require sequenced engagement with multiple authorities, with regional advice reconciled into one executable global development plan.
Implementing advice
Translating health authority feedback into the right development decisions takes experienced regulatory judgment.
Cross-functional alignment
Clinical, nonclinical, CMC, quality, statistics, safety, and device positions must be integrated before presenting questions to an authority.
Proven regulatory strategy across every major agency
Cencora supports interactions across the FDA, EMA scientific committees, and national agencies worldwide, from early scientific advice through post-approval follow-up.
We can help you set strategy, prepare and lead meetings, and turn agency feedback into clear next steps, drawing on local regulatory experts.
We can help you set strategy, prepare and lead meetings, and turn agency feedback into clear next steps, drawing on local regulatory experts.
What we offer
Scientific advice and early engagement
PRIME eligibility, orphan designation, protocol assistance, pediatric development, and accelerated regulatory pathways in key markets.
FDA meetings
Strategy and execution across pre-IND, end of phase, pre-NDA, Type A, B, C, D, and biosimilar meetings.
EMA and committee interactions
Engagement with SAWP, CHMP, PRAC, COMP, PDCO, and CAT, as well as national health authorities across key markets.
Medical device and product interactions
Q-Submission and Pre-Submission support, CBER submissions, human factors, and combination product strategy.
Meeting preparation
Regulatory strategy, briefing package authoring, delegate coaching, and rehearsal to ensure your team is fully prepared.
Follow-up and implementation
Interpretation of agency responses, meeting minutes, and translation of advice into program strategy and next steps.
Why choose Cencora for health authority interactions
Integrated content development
Clinical, nonclinical, CMC, quality, and safety specialists build one aligned position before your questions ever reach an authority.
Coordinated global engagement
One team sequences interactions across the FDA, EMA, and national agencies and reconciles their advice into a single plan.
Rapidly assembled expertise
Experienced regulatory teams come together quickly around your program, so engagement timelines are not held up by staffing gaps.
Expert insight
Proactive, credible engagement with global health authorities signals that a biotech is not only developmentally sound but also commercially viable.
— Michael Day, PhD
Breaking through early development challenges: BIO panel takeaways
Related solutions
Integrated submission readiness assessment
Navigate NDA, BLA, and MAA submissions with cross-functional regulatory support and an independent readiness assessment before filing.
Regulatory writing
Turn complex scientific, clinical, and quality data into clear, accurate, submission-ready documents across development and lifecycle management.
PharmaLex is now Cencora
Health authority interactions is part of our Commercialization support capability. Same team, same expertise, now with greater reach.
Need more information about health authority interactions?
Our team of experts is here to assist you. Whether you have questions or need more detailed information, don’t hesitate to get in touch. We’re dedicated to providing the support you need.