Overview

Freyr has a specialty Regulatory/Compliance group situated in close proximity of the FDA Headquarters in Maryland.  We offer a wide range of regulatory compliance services and end-to-end support to healthcare companies to effectively:

  • Develop regulatory/compliance strategies
  • Build functional regulatory departments
  • Liaise with FDA and other Regulatory Authorities
  • Conduct face-to-face meetings with FDA
  • Perform due diligence
  • Complete gap analyses
  • Carry out GxP functions
  • Prepare technical documentation
  • Compile and submit global regulatory submissions

 

 

Services Highlights

Freyr provides GxP auditing and training in the areas of GMP, GCP and GLP to assist in streamlining drug development to assure compliance, targeting vendors for qualification, protocol execution, and safety oversight.
Additionally, we also provide strategic oversight on functional SOPs, ease of Operations, Quality and offer Quality review.  Our high track record of success has led to smooth and timely Regulatory/ Compliance acceptance and Regulatory approvals from FDA.
As a preferred services partner, Freyr can complement your clinical activities associated with Regulatory Authority requirements by providing diverse clinical affairs solutions, including regulatory planning, regulatory assistance in executing clinical trials and safety reporting that will withstand the review and examination of the FDA.
Freyr assists its global clients, both in the emerging markets and in the EU region, to effectively communicate with the US FDA for their unique regulatory requirements / product approvals in the following Therapeutic Divisions:
  • Medical Imaging
  • Anti-Infectives
  • Oncology
  • Endocrine and Metabolism, and
  • Ophthalmics
 

Freyr Capabilities

Our diverse high-level regulatory affairs consulting services subject to the jurisdiction of FDA and other Regulatory Authorities span across clients’ unique operational functions, such as:

Clinical Affairs

  • Regulatory planning
  • Regulatory assistance in executing clinical trials
  • Safety reporting that will withstand the review and examination of the FDA

CMC Regulatory Consulting

  • Regulatory CMC Strategic Development
  • GMP Quality Services (GMP auditing, mock inspections, due diligence qualifications of facilities, Labs, writing SOPs, building GxP Quality Vendor Certification and strategic development)
  • Strategic Project Planning
  • Experience with established and novel pharmaceutical dosage forms
  • Synthetic assessment in preparation of active pharmaceutical ingredients
  • Stability probability assessments
  • Test method and validation assessments
  • Due diligence activities in support of the sale or purchase of a product
  • FDA Submission (eCTD or Paper) Planning and Development (INDs, NDAs, ANDAs, DMFs, Annual and Periodic Reports); QC oversight
  • FDA Liaison Activities
  • Consultation on CMC Drug Substance, Drug Product, and Analytical issues
  • CMC Report Writing
  • Regulatory Review of CMC Documentation
  • On-site seminars.

Drug Development

  • GxP auditing and training in the areas of GMP, GCP and GLP to streamline drug development and to assure compliance targeting vendors for qualification, protocol execution, and safety oversight
  • Strategic oversight on functional SOPs, ease of Operations, Quality and offer Quality review

Freyr Expert Reviewer Team

Freyr has a team of highly specialized exFDA experts and senior FDA Chemistry reviewers. The experts bring a rich experience of over 6 years with FDA, having worked in various CDER Therapeutic Drug Divisions of the Center for Drug Evaluation and Research with consulting ties to both Biologics and Devices, coupled with over 20 years of experience in the pharmaceutical industry across positions ranging from Senior Scientist to Director to Vice President Responsibilities.

The teams’ converged interests over the last decade have been directed towards building Regulatory CMC and Clinical Strategies and creatively building Regulatory Communication and Submission Strategies for Clients communicating with FDA in the following Therapeutic Divisions:

  • Medical Imaging
  • Anti-Infectives
  • Oncology
  • Endocrine
  • Metabolism
  • Ophthalmics

CLIENT TESTIMONIALS

 
  • Under the EMA’s tight timelines, your resource has successfully delivered on commitments with overwhelming speed and decisiveness ensuring we met the requirements on time. We just wanted to recognize their hard work and diligence on the product information update for a drug. Within just few weeks of their stint at our organization, they successfully navigated our processes and integrated them into the product team. Quite impressive! We must reiterate!

    Senior Regulatory Associate, Worldwide Regulatory Strategy
    A leading research-based global Biopharmaceutical Company

  • On behalf of the entire team, I’d like to thank you for your hospitality. We understand that hosting us took time away from your day-to-day activities, and we just wanted to say thank you for everything you did to make this a very interactive, productive and successful visit for us. We would especially like to pass along our appreciation to the entire Freyr team for partnering in our mission to serve patients.

    - Director, Supplier Performance Management, Global Regulatory Affairs & Safety
    Forbes Global Top 10 Biopharma Company

  • Thanks so much for all the help and diligence. We are so impressed by the way things have been handled by Fryer and the level of competence.

    We have another very similar project coming up in the next few weeks where we need exactly the same level and type of service which we will be delighted to talk to you further.

    – Program Manager, Regulatory Affairs – Global $1Bn Pharma Company

  • Thanks for the great work you are doing, sharing the great principles that Freyr uses for its employees and your focus on sustainability.

    – Head of Procurement, Fortune 100, Global Top 10 Consumer Healthcare & Pharma Company