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:
- electrical safety
- software validation
- laboratory analysis and more.
At a Glance:
ISO 14971 risk management
Standards regulatory guidance and pharmacopoeial compliance
Bridging study advice
Product safety testing