Product Development and Standards

Even in an era of harmonisation, local regulations vary widely. The art is in building comprehensive understanding of technical requirements and standards and matching these to the various regulatory processes. Brandwood CKC helps you to build a core data set to generate multiple international filings.

We work with you ensure your development processes generate technical data which meet the rigorous expectations of regulators.

Our team includes experts in:

  • biocompatibility
  • electrical safety
  • software validation
  • bioavailability
  • pharmacokinetics
  • formulation
  • biotechnology
  • laboratory analysis and more.

At a Glance:

  • Technical Files

  • ISO 14971 risk management

  • Standards regulatory guidance and pharmacopoeial compliance

  • Bridging study advice

  • Bioavailability/bioequivalence justifications

  • Design controls

  • Product safety testing

Let Us Know What You Think

If you've got any questions or would just like to learn more about what how we could work together, then get in touch.