RegExcel Consulting
Helping you get regulatory approval
info@regexcelconsulting.com
Please contact us for a free discussion about your service needs.
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.
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.
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.
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.
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!"
Product Development
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Regulatory Requirements/Strategy
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Post-approval Maintenance
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