Regulatory Center of Excellence
Advance Approvals While Anticipating and Mitigating Risks
Advarra’s Regulatory Center of Excellence helps clients successfully navigate the continuously evolving regulatory environment.
Regulatory Expertise For All Stages of Product Development and Lifecycle
Early Development Plan
- Gain FDA buy-in to registration strategy early to de-risk program
Justify Safety of Clinical Regimen
- IND-enabling safety/toxicology package
Nonclinical Evidence of Effect
Characterize Investigational Drug
- Phase I PK (SAD/MAD)
Demonstrate Safety and Early Efficacy
- Improve drug formula based on info gained
- Develop optimized drug product formula for commercialization
- Identify final label claims
- Compile application and submit to FDA for review
Strategic Development Support
Develop the strategy, build the roadmap, and anticipate challenges to meet critical milestones with confidence.
Regulatory Pathway Assessment
- Guidance throughout the pre-commercial product development process and post-commercial product lifecycle
Accelerated Pathway Assessment
- Fast-Track, Breakthrough Therapy Accelerated Approval, Priority Review assessment, Orphan, Rare Diseases, Pediatric exclusivity
Post-Commercial Life Cycle Issues
- CMC and Label Changes
- Changes due to new regulations or operational issues
Due Diligence Services for M&A Activity
- FDA 438 and warning letter implications
Advarra brought focused expertise that allowed us to aggressively move forward. Very rarely do you have an opportunity to see the drug go from filing to approval. It’s a 1 in 5 shot. Advarra enabled that to happen. They were a real cornerstone at the beginning of that process that enabled our success.
– VP of Commercialization
Submissions & Regulatory Operations
Effectively advance your regulatory strategy with operational support when and where you need it.
- Prep/facilitation of Pre-IND, End of Phase, and pre NDA/BLA Submission Meetings
- Briefing Package
- IND, NDA, ANDA, BLA Applications
- Technical Writing/CMC Documentation
- eCTD Publishing
- Annual Reports, CBEs, Supplements
- Advertising and Promotion Review/Oversite
Thanks to Advarra, we were able to get the flexible resources we needed and create higher-quality deliverables than what we would have ever been able to create ourselves. They also helped identify additional areas of improvement for our organization.
– VP, Regulatory Affairs
The IND Journey - Regulatory Expertise for Emerging Biotech and BioPharma
from nonclinical to first-in-human
the regulatory pathway
expert knowledge on how to get to the pre-IND meeting
the pre-meeting briefing document
FDA meetings and submit responses to FDA feedback
and submit the full IND
A Snapshot of Our Regulatory Expertise
Sharon Ayd, MBA, PhD
VP & Principal, Regulatory Center of Excellence (COE)
Sharon Ayd is a veteran in leading scientific teams at multiple organizations. With extensive experience in translational science, clinical development, regulatory affairs, go-to-market strategy, and operations, as well as product lifecycle management, Ayd’s assisted in developing successful commercialization of biopharmaceuticals and combination products. Ayd shares her passion and experience in life sciences as an adjunct professor at Northwestern University and at the University of Wisconsin as well as a published author. She has a bachelor’s degree from Northeastern Illinois University, an MBA from Lewis University, and a Ph.D. from the University of Illinois.
Norma Ascroft, Pharm D
Former Sr. Director of US Regulatory Affairs at Eli Lilly
Anne Marie Finley, MSc, DBA
Former VP of Government Regulations & Public Policy at Celgene
Brian Harvey, MD, PhD
Former VP of US Regulatory Strategy at Pfizer
Anthony Waclawski, PhD
Vice President and Head, Regulatory and Pharmaceutical Sciences, CV, IS, Fibrosis, and GDD at BMS
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