Generic: Discovery: Cambridge Regulatory Services

Early Development Phase

So you've decided to develop a generic version of a novel 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.

Do you have the regulatory resource and experience to get your product to market ahead of the competition?

It is a common misconception that "you only need regulatory affairs when you are ready to submit for approval". This could not 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, increasing your chances of speedy and successful registration.

Our Services include:

• Providing honest regulatory advice
• Establishing the patent status of the innovator product
• Sourcing intelligence on what is already on the EU market
• Developing a regulatory strategy, including type of application (e.g. hybrid etc.)

Do you know enough about the regulatory framework to make it work to your advantage?

Are you aware of the latest guidelines relevant to your product?

What does eCTD (Electronic Common Technical Document) mean to you?

Generic: Discovery

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

YOUR PARTNERfor a full Regulatory Affairs Service

Early Development Phase

Do you know enough about the regulatory framework to make it work to your advantage? Are you aware of the latest guidelines relevant to your product? What does eCTD (Electronic Common Technical Document) mean to you?

YOUR PARTNER
for a full Regulatory Affairs Service

Do you know enough about the regulatory framework to make it work to your advantage?

Are you aware of the latest guidelines relevant to your product?

What does eCTD (Electronic Common Technical Document) mean to you?