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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Clinical Phase

Generic: ClinicalDepending upon the type of generic product you are developing, you may need to conduct clinical trials in order to demonstrate bioequivalence to the originator's product. This will be an important phase for you as for the first time you will be seeing how your product behaves in humans.

During this critical time it is more important than ever that you work with real experts. We will champion your product and remain dedicated to the project until your medicine has reached the market and is benefiting patients.

 

Our Services:

 

• Clinical programme advice
• CTA (writing & submission)
• Seeking ethics committee approval
• Recommending opinion leaders
• Recommending a CRO to execute your biostudies
• Arranging GCP mock inspection

Have you an established working relationship with a quality CRO experienced in Phase 1 studies?

 

Are you experienced in preparing CTAs?

 

Do you need advice on how to optimise your study protocol (e.g. use of parallel, sequential or steady-state design)?

 

 

Take advantage of our knowledge and experience during this important phase of your product development.


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CambReg: Your Partner for a full Regulatory Affairs Service
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