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Discovery Phase

So you've made an exciting discovery of a potential new drug? You've identified your drug candidate and carried out pharmacology studies to support its development into a therapeutic entity. Now do you have the regulatory resource and experience to turn your discovery candidate into a marketed medicine?

It's a common misconception that "you only need regulatory affairs when your Research and Development is complete". This couldn't be further from the truth because everything that you do from this stage onwards must be done to standards that will satisfy regulatory authorities in world markets.

Do you fully understand the regulatory framework in which you need to work?

Are you aware of the latest guidelines relevant to your product and its therapeutic area?

What does CTD (Common Technical Document) mean to you?

Taking early advice on your development programme means early to market. The key to success is to plan and spend money on studies wisely.

If your product is for a rare disease, it may be eligible for Orphan Drug Designation. Let us inform you of the commercial advantages.