Pre-Clinical And Clinical Regulatory Consulting

Responding To Regulatory Inspection Observations: Do’s and Don’ts

CCRM’s extensive knowledge in cell and gene regulatory affairs can help you de-risk your projects at any stage of development, from early stage preclinical planning through to global commercialization. We have experience negotiating clinical trials and new product commercialization with regulators around the world and can leverage this to help you design a go-to-market regulatory strategy appropriate to your regenerative medicine technology, saving you time and money and improving predictability.

Personalized regulatory advice and support services include:

  • Interpretation and explanation of regulatory context
  • Assistance developing strategic regulatory plans to drive your commercialization strategy
  • Identifying opportunities to reduce regulatory unknowns in project planning
  • Guidance and support throughout the preparation and submission process, including leading interactions with regulators such as FDA and Health Canada