RegExcel Consulting

Helping you get regulatory approval

info@regexcelconsulting.com

 

Please contact us for a free discussion about your service needs.

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A Regulatory Consultancy with Agency Roots.


We provide regulatory and strategic advice for small molecules through to large biotech proteins, vaccines and ATMPs.


RegExcel consultants are all ex-regulators. This unique RegExcel feature means you get advice from consultants that have previously been responsible for making decisions as a regulator – consultants that have actively participated in National and European committees, given scientific advice to companies over years and read hundreds of regulatory dossiers ranging from those of multinational companies down to start-ups. 

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SMART
MOVES

We believe the key to success in this Industry is making the right decisions at the right time.  We work with our clients to ensure you meet regulatory expectations appropriate to your stage of development, whilst ensuring you stay on the Critical Path and make best use of your resources.

STRIKING
RESULTS

Our regulatory experience enables you to  navigate regulatory issues and pitfalls during development of your product - be that preparing for clinical trials or marketing authorisation.  Appropriate management of the risks (CMC, efficacy, safety) will mean quicker progress to your goals.

FRESH

SOLUTIONS

There is always more than one way to look at a problem. We use our extensive regulatory  experience to enable you to make informed decisions on your strategy.  Our advice is  pragmatic and feasible whilst ensuring regulatory risks are appropriately identified and addressed.

OUR

THINKING

We work with our clients to help them achieve their goals efficiently, quickly and with confidence.  Public health benefit and better access to medicines remains at the forefront of our philosophy.  At all times, you can be assured that we work with integrity and maintain confidentiality.

"I hired Brij as a regulatory advisor and haven't looked back. He is a fount of information on the latest regulatory guidelines, strikes the right balance between recommending the smoothest route for the company and standing firm on the 'must haves'. His response times are quick and he's not afraid to roll up his sleeves and go the extra mile. A true professional!"

Research a Business Opportunity

Product Development
Speak to us about:

  • Identifying regulatory risks for your product;
  • Supporting due diligence;
  • The design of your CMC/pre-clinical and clinical studies.

Regulatory Requirements/Strategy
Speak to us about:

  • Legal basis for your product;
  • Data requirements;
  • How to prepare your IMPD/MAA;
  • Dealing with regulators;
  • Determining a positive Benefit:Risk ratio.

Post-approval Maintenance
Speak to us about:

  • Regulatory conformance;
  • Preparing for post-approval variations;
  • Dealing with defective medicines.