Product Development and Standards

While we are working in an era global regulatory harmonisation, local regulations vary widely. The art is in building comprehensive understanding of technical requirements and standards and matching these to the varying regulatory processes in different markets. Brandwood CKC helps you to build a core data set from which multiple international filings can be generated.

We work with you ensure your development processes generate technical data that 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

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