MEDEIRA CONSULTING

Regulatory and Drug Development Consulting / FDA Submissions

Strategic Consulting for Drug Candidates

We provide integrated strategic, regulatory and drug development consulting on drug candidates from pre-clinical research and pre-clinical IND enabling work to IND opening and to various phases of clinical development, and to NDA/BLA filing, including the following key disciplines:

  • Pharmacology and Toxicology;

  • Drug Metabolism and Pharmacokinetics (DMPK);

  • Clinical Pharmacology;

  • Clinical Development;

  • Chemistry, Manufacturing and Controls (CMC);

  • Current Good Manufacturing Practice (CGMP) Compliance;

We also help clients to prepare and submit Fast Track Designation, Breakthrough Therapy Designation, and Orphan Drug Designation Requests.