CambReg: Cambridge Regulatory Services: Your Partner for a full Regulatory Affairs Service

YOUR PARTNER
for a full Regulatory Affairs Service

CambReg: Your Partner for a full Regulatory Affairs Service

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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 your route of synthesis carefully before you embark on your non-clinical and clinical programme, ensuring that your production methods are commercially scalable.

 

Consultancy Services:

 

• Gap analysis

• GMP compliance, mock inspection

• Recommendation of relevant contract houses

 

Dossier compilation services:

 

• Certificate of Suitability

• DMF Application
• TSE Certification
• Module 3 and Quality Overall Summary preparation

Will you have enough material to start your preclinical studies?

 

Are you embarking on key studies with material with an unrepresentative impurity profile?

Will you have enough stability data to support your Clinical Trial Application?

 

NCE: 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.


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CambReg: Your Partner for a full Regulatory Affairs Service
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