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
Preclinical
Early Development Plan
- Gain FDA buy-in to registration strategy early to de-risk program
IND
Justify Safety of Clinical Regimen
- IND-enabling safety/toxicology package
Nonclinical Evidence of Effect
Phase I
Characterize Investigational Drug
- Phase I PK (SAD/MAD)
Phase II
Demonstrate Safety and Early Efficacy
- Improve drug formula based on info gained
Phase III
Demonstrate Efficacy
- Develop optimized drug product formula for commercialization
- Identify final label claims
NDA
Marketing Approval
- Compile application and submit to FDA for review
Tailored Offerings
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.
FDA Meetings
- Prep/facilitation of Pre-IND, End of Phase, and pre NDA/BLA Submission Meetings
- Briefing Package
Submissions Support
- IND, NDA, ANDA, BLA Applications
- Technical Writing/CMC Documentation
- eCTD Publishing
- Annual Reports, CBEs, Supplements
Program Management
Labeling Review/Oversite
- 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
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
Scott Oglesby
Managing Expert
Anthony Waclawski, PhD
Vice President and Head, Regulatory and Pharmaceutical Sciences, CV, IS, Fibrosis, and GDD at BMS
Alethea Wieland
President, COO & Founder at Clinical Research Strategies
A Partner You Can Count On
“I knew I did not have the knowledge to shepherd this through an FDA filing without the experts who had done this many times before … in just three weeks we had working units in testing … and in five weeks, we had an FDA Emergency Use Authorization in hand. Wow, this just could not have happened without such a dedicated team with very broad skills and experience.”
Client’s President
“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.”
Client’s VP of Regulatory Affairs
“The speed with which we were able to move with Advarra helped us get [our] submission in sooner, and it also allowed for a much more high-quality submission with the FDA…We saved a considerable amount of time, which equated to saving, arguably, millions of dollars on the timeline to really get our approval moving forward with the FDA more quickly.”
Client’s Chief Financial Officer
Related Resources
Top Three Reasons Why Your Medical Device Needs a Clinical Trial
Interpreting evolving regulations for medical devices is a common challenge for emerging biotech companies.
FDA Guidance Offers New Flexibility to Biotechs in Cell and Gene Therapy
FDA recently released new guidance, potentially impacting early-phase cell and gene therapy trials.
Your Guide to sIRB Mandates
sIRB regulations and policies have been announced and implemented to help address the challenges of conducting clinical trials involving multiple research sites.
