RegExcel Consulting

Helping you get regulatory approval

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Learn more about us...


E-mail: info@regexcelconsulting.com



Or contact our lead consultant directly:


E-mail: brij.patel@regexcelconsulting.com

 

Phone: +44 (0) 7961370272


Research a Business Opportunity

Pre-approval Product Development

Speak to us about:

- Identifying regulatory risks for your product;


- Supporting due diligence activities;


- The design of your CMC, pre-clinical and clinical studies.

Regulatory Requirements and Strategy


Speak to us about:

- Legal basis for your product;


- Data requirements;


- How to prepare your IMPD/MAA;


- Dealing with regulators;


- Achieving a positive Benefit:Risk ratio.

Post-approval Maintenance

Speak to us about:

- Regulatory conformance;


- Preparing for post-approval variations;


- Dealing with defective medicines;