So
you have decided to develop a generic version of a novel biological
medicine. You are now in a race against time to make sure
that you will be first to the market after patent expiry of
the innovator product.
Now do you have the regulatory resource and experience to
get your candidate product to a market ahead of the competition?
It is a common misconception that "you only need regulatory
affairs when your development phase is complete". This could
not be further from the truth because everything that you
do from this stage onwards must be done to standards that
satisfy regulatory authorities in world markets.
Our
Services
At this stage we can help
with:
• Honest regulatory advice
• Recommendation of experts in your field
• Recommendation of contract houses for subsequent
development
• Orphan Drug Designation advice
Can your product be handled as a biosimilar from a regulatory
perspective?
Are you aware of the differences in regulatory requirements
in the USA/EU?
Have you chosen the right reference product?
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Taking early advice on your development programme means early
to market. The key to success is to plan and spend money on
studies wisely.
”As somebody who has over 25 years
experience in pharmaceutical R&D, I found the performance
of Cambridge Regulatory Services Ltd to be way above average
for regulatory affairs consultancies and would not hesitate
to use their services again”.
(JD - ENACT)
Make sure
you can satisfy Health Authorities in the EU, USA and Japan
with one data package.
So
you have decided to develop a generic version of a novel biological
medicine. You are now in a race against time to make sure
that you will be first to the market after patent expiry of
the innovator product.
