Biotechnological clinical quality management

Sunnikan supports biotech companies

Sunnikan offers tailor-made support for companies moving over into clinical phases, in addition to 'Genetically-Modified Organism' (GMO) regulatory monitoring.

Supporting the transition to clinical phases

Moving into clinical phases is always a complex task for biotech companies, as this process involves new regulations, new areas of responsibility, and new required skill-sets.

The support Sunnikan provides these companies can include:

  • Training (in regulations, clinical processes, clinical quality management, etc.)
  • Setting up a basic quality management system
  • Drawing up the standard operating procedures that are strictly necessary, but which will change as the clinical trials evolve.

'Genetically-Modified Organism' (GMO) regulatory monitoring

The scope of Sunnikan's 'Genetically-Modified Organism' (GMO) regulatory monitoring includes specific regulations pertaining to basic research, pre-clinical research (GMO handling, transgenic animals, administering GMOs to animals) and clinical research surrounding GMOs.

  • Products involved: innovative therapeutic medication that contains or is based on a GMO
  • Research reference frameworks: legislation, French, EU and international regulations and recommendations (ICH, the Convention On Biodiversity and the Nagoya Protocol)
  • Indirectly related frameworks such as GMO deliberate release and contained use

The scope of application is essentially restricted to French and EU regulations (EMA, European Commission).

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As a training body, Sunnikan offers regulatory and quality training sessions

Our regulatory monitoring

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Sunnikan offers monitoring and support tools to help companies keep up to speed on their regulatory obligations