We specialize in regulatory affairs and have extensive experience helping clients navigate the complex and ever-changing regulatory landscape from proof-of-concept to product approval. Our team has worked with regulatory authorities around the world and our depth of knowledge ensures that we consider regulatory strategies at every stage of product development for a successful clinical trial. Our submission strategies support all aspects of clinical development from early stages through product registration and post-marketing.

Amarex is located near the U.S. FDA, our team is led by an experienced clinician with more than a decade of Regulatory Affairs experience, and we leverage these invaluable regulatory resources at every opportunity, offering our clients the best representation when exhibiting the science, safety and efficacy of their medical products to regulatory agencies.

Our regulatory team helps sponsors prepare and deliver their application with confidence. We provide reliable, specialized support throughout the entire project life cycle. Backed by 25+ years of industry experience, our fully integrated Regulatory team develops customized submission strategies that save clients time and money.

Our services include:

Regulatory Consultation

• Identifying potential regulatory hurdles and developing mitigation strategies by conducting a Regulatory Gap Analysis.
• Product development assessments
• Identifying and mitigating regulatory risks

FDA Regulatory Submissions and Documentation

• Preparing and submitting various types of regulatory applications including:
  • IND
  • IDE
  • 510(k)
  • NDA
  • BLA
  • PMA
  • ANDA
  • Drug Master File (DMF), etc.
• Maintaining Regulatory applications (submitting annual reports, progress reports, safety reports, application amendments and supplements)
• Maintaining and organizing regulatory documentation

Preparation and Submission of Special Request

Requests for different designations including:

• Orphan Drug Designation (ODD)
• Breakthrough Therapy Designation for Drugs and Medical Devices
• Regenerative Medicine Advanced Therapy (RMAT)
• Rare Pediatric Disease Designation
• Fast Track
• Rolling Review
• Accelerated Approval
• Priority Review

Interactions with Regulatory Authorities

• Act as the US Agent for regulatory applications
• Liaising with regulatory agencies to address questions and obtain approvals

Meetings Between the FDA and Sponsors

• Preparation of meeting request and package for variety of FDA meetings including:
  • Type A
  • Type B (Pre-IND, Pre-BLA, Pre-NDA, End of Phase)
  • Type C
  • Type D
  • INTERACT
  • Biological Product Development (BPD)
  • Q-sub (Pre-submission)
• Preparing, attending and leading interactive meetings with the FDA (teleconference, videoconference and in-person meetings)
• Response to the FDA preliminary feedback or interactive questions

Electronic Services

• eCTD preparation and publishing (US, EU, HC, other regions)
• Labeler code, Structured Product Label (SPL)
• eCopy and eSTAR
• CDER NextGen submissions

Additional Regulatory Services

• Registration and Maintenance of clinical trials on NIH registry of clinicaltrials.gov
• Developing product labeling and packaging that comply with regional regulations
• Pediatric applications Initial Pediatric Study Plans (iPSP), Pediatric Investigation Plan (PIP)
• Special Protocol Assessment (SPA)
• New dietary ingredient (NDI) applications
• Managing vendors and committees like Adjudication committee

Global Regulatory Applications

• Submissions to international regulatory agencies including but not limited to:
  • Health Canada
  • EMA
  • MHRA
  • NMPA
  • Taiwan FDA
  • DCGI
• Setting and letting meetings with the regulatory agencies
• Helping sponsors transition clinical trials from the Clinical Trials Directive (CTD) to the Clinical Trials Regulation (CTR)
• European regulatory applications and submissions (including CTA, MAA, IMPD, IB, SmPC, OMPD, PIP, etc.) through CTIS and other portals
• Act as Responsible Person (RP)
• Drug substance and Drug product registration on EudraVigilance XEVMPD.