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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.

Medical Staff symbol in a box with CRO and Sponsor icons

Achieve Your Drug and Device Development Goals

We are veteran industry leaders who know what it takes to get products to market while successfully anticipating and mitigating risk. We understand the process and bring unparalleled scientific knowledge and long-standing relationships. Advarra Consulting experts work alongside clients helping you to understand what’s needed and deliver with excellence.

Tailored Offerings

Develop the strategy, build the roadmap, and anticipate challenges to meet critical milestones with confidence.

  • Full-service programs
  • Targeted objectives
  • Due diligence

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

Effectively advance your regulatory strategy with operational support when and where you need it.

  • Meeting preparation
  • IND, BLA, NDA applications
  • Briefing packet development
  • Medical writing/CMC documentation
  • Project management
  • Labeling
  • Advertising and promotion
  • Strategic regulatory counsel
  • Monitoring and surveillance

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

Understand the potential impact of regulatory changes on your regulatory programs and business and get experienced counsel to ensure you have a voice when you need it.

  • Strategic regulatory counsel
  • Monitoring and surveillance
  • Organization assessments
  • Education and training

Advarra puts together very seasoned professionals, so they know how to get things done. But importantly they’re team players. They never put their egos in the way. A real advantage of working with that team is they fully integrate into your organization. All the politics are set aside and the finish the job attitude is just front and center.

Let our Experience be Your Advantage

At Advarra, we are more than regulatory experts. We are former executives and practitioners. We are professionals with deep experience getting life changing products into the hands of consumers and participants. We are FDA veterans with long-standing relationships.

We have worked across all therapeutic areas and classifications including 505(b)(2)s, new chemical entities, orphan drugs, generics, combination products, and more. We know what it takes to advance the drug development process. We stand ready to help you deliver.

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

Graham Higson, MSc
Former VP, Regulatory Affairs, Avillion

Steve Pondell, BS, MBA
Former VP CMC & Operations at ImmunoMet Therapeutics

Anthony Waclawski, PhD
Vice President and Head, Regulatory and Pharmaceutical Sciences, CV, IS, Fibrosis, and GDD at BMS

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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