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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

TRANSLATE​

from nonclinical to ​first-in-human

DEFINE​

the ​ regulatory pathway

PROVIDE​

expert knowledge on how to get to the pre-IND meeting

PREPARE​

the pre-meeting briefing document

FACILITATE​

FDA meetings and submit responses to FDA feedback

COMPILE​

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

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