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Regulatory Affairs

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 expert 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 early clinical development, product registration and late-phase trials.

Amarex is located near the U.S. FDA, our team is led by a former FDA reviewer 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.

IND Submissions

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 20+ years of industry experience, our fully integrated IND team develops customized submission strategies that save clients time and money.

Our services include:

  • FDA applications and submissions: IND, IDE, 510(k), NDA, BLA, PMA, ANDA, orphan drug designation (ODD), request for designation, breakthrough therapy and fast track
  • New dietary ingredient (NDI) applications
  • Regulatory strategy
  • CMC expertise
  • International regulatory agency submissions (CTA, IMPD, MA and CE) and meetings
  • Adjudication committee management
  • GLP, GCP, GMP and GAP audits and certifications
  • Clinical research results evaluation
  • Clinical development plan
  • Product development assessments
  • Clinical research seminars and trainings
  • Regulatory affairs IND-enabling guidance (preclinical and manufacturing)
  • eCTD and eCopy formatting and submissions
  • Global consulting (separate from certification)
  • Male nurse with staff in hospital - Clinical | Amarex

    Clinical

    We offer complete clinical operations, clinical site feasibility and risk-based monitoring services.
  • Group of Business People during Brainstorming Presentation - Project Management Services | Amarex

    Project Management

    Improved, continuous communication and increased accountability ensure that the project stays on track, on time and within budget.

Contact Us

Book a meeting or send us a message to talk to one of our experts.