Regulatory Consulting

Understanding and evaluating the complex regulatory environment for every new product can be an intimidating process. Our regulatory consulting staff, some of whom have served on FDA, EPA, OECD and WHO advisory panels and hail from previous senior-level positions within industry or government, can play a key role on any project by providing you with support during preclinical and clinical development, manufacturing, product licensing and regulatory approvals. Areas of expertise include pharmaceuticals, biologics, medical devices, veterinary medicines and agrochemicals.

Services

  • Development and registration strategies
  • Data review, gap analysis and strategic advice
  • Documentation and presentation coaching
  • Expert report preparation
  • Clinical trial applications and trial support services
  • Product license variations and defense
  • Product life cycle management
  • Participation on scientific and regulatory advisory boards
  • Scientific and regulatory training on the preclinical aspects of drug development

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Safety Assessment

Our exceptional team of scientists designs and performs safety programs ranging from acute through chronic toxicity and carcinogenicity studies.

Discovery Services

Establish the pharmacokinetic efficacy and safety profiles of your discovery program's compounds.