TMC has extensive experience in investigational new drug-enabling (IND) activities, including non-clinical studies and manufacturing support.

Non-Clinical Services

  • Our experts review data for regulatory acceptability and advise on development strategies

  • We advise on requirements and liaise with third-party toxicology providers

  • We identify relevant academic units and personnel for early-stage advice

Manufacturing & Quality Assurance Services

  • Employment of a pragmatic and experienced qualified person (QP) who will:

    • Review data for regulatory acceptability, compile investigational medicinal product dossiers (IMPDs) and advise on the development strategy
    • Audit manufacturing sites for compliance with good manufacturing practices (GMP)
    • Provide EU QP certification for clinical trials
  • Location of high-quality GMP units, particularly those able to produce special batch sizes

  • Liaison with clinical trials supplies management units, importers and distributors

  • Management of import and QP release of investigational and marketed drugs in the EU and other territories

Get In Touch

Our team is ready and willing to support your non-clinical needs.

To discuss your specific project requirements, contact us today.