Generic: Quality: Cambridge Regulatory Services

Quality (Chemistry, Manufacture and Control - CMC)

You know that there will be CMC issues throughout the life of the product. Get ahead of the competition by learning from us where the pitfalls are and how to avoid them. Consider what stage you are at in product development before you embark on your clinical programme.

Our Services include:

• Providing experts for GMP compliance mock inspections

• Undertaking a thorough ‘Gap Analysis’ of your CMC submission documents

• Recommending relevant contract houses

• Preparing your CTD Module 3

• Writing your Module 2 Quality Overall Summary

• Applying to the EDQM for Certificates of suitability (including TSE certification)

Have you identified the optimal dissolution test for your product?

Do you know how to show an in vivo/in vitro correlation for your product?

Scientific Advice from the Health Authorities may be advantageous to you at this stage.

Generic: Quality

Take advantage of our strong in-house CMC team headed by Dr Mike James (ex-MHRA assessor with more than 20 years' regulatory experience) and choose the most cost-effective route for your products.

YOUR PARTNERfor a full Regulatory Affairs Service

Quality (Chemistry, Manufacture and Control - CMC)

Have you identified the optimal dissolution test for your product? Do you know how to show an in vivo/in vitro correlation for your product? Scientific Advice from the Health Authorities may be advantageous to you at this stage.

YOUR PARTNER
for a full Regulatory Affairs Service

Have you identified the optimal dissolution test for your product?

Do you know how to show an in vivo/in vitro correlation for your product?

Scientific Advice from the Health Authorities may be advantageous to you at this stage.