REGULATORY AFFAIRS

COLLABORATION

Amarex's regulatory department has vast experience working with expert regulatory authorities around the world. Our expertise ensures that regulatory strategies are considered at every step to help gain product registration. We provide submission strategies that support early clinical development, product registration and late-phase trials.

Our competitive advantage lies in the experience we have guiding our clients from strategy to FDA submissions. Our experience enables our clients to have the best representation when exhibiting the science, safety and efficacy of their medical product to regulatory agencies.

IND SUBMISSION

Our regulatory team helps clients prepare and deliver their applications with confidence, providing reliable, specialized support throughout the entire project life cycle. Backed by 20+ years of industry experience, our fully integrated IND team develop customized submission strategies designed to save clients time and money.

Services include:

  • FDA Applications and Submissions: IND, IDE, 510(k), NDA (eCTD), BLA, PMA, ANDA, Orphan Drug Designation and Break-through Therapy Designation

  • Regulatory Strategy

  • CMC Expertise

  • International Regulatory Agency Submissions (CTA, IMPD, MA, CE) and Meetings

  • GLP, GCP, GMP, GAP Audits and Certifications

  • Clinical Research Results Evaluation

  • Clinical Development Plan

  • Product Development Assessments

  • Regulatory Affairs IND Enabling Guidance (Pre-Clinical & Manufacturing)

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