Regulatory Strategy Consultants

The old adage ‘failing to plan is planning to fail’ could not be any truer when considering your regulatory strategy. A carefully crafted regulatory strategy is crucial when a company wishes to market their product across regions subject to different regulatory requirements.  Acorn Regulatory can assist your company in developing a robust regulatory strategy.

Pharmaceutical Regulatory Strategy

One of the most critical elements in developing your strategy is devising upfront a target product profile (for the US) or a Quality Target Product Profile (QTPP, for the EU). The QTTP is a document that summarises the key goals of a drug development program and is typically used to convey information the sponsor intends to include in a product’s labelling or to detail critical manufacturing or quality attributes of a product.

We have significant experience of assisting companies, of all sizes, in devising their target product profile/quality target product profile.

Our approach to strategy development is built upon almost 20 years of working with clients around the world.

Medical Device Regulatory Strategy

The ever changing device sector is one where we have a well deserved reputation for assisting companies in developing their  strategy.  Acorn Regulatory works with companies of every size that manufacture products across every possible classification.  Our medical device team utilises their extensive experience gained in national health authorities and at leading medical device manufacturers to guide client companies.

Our team of experienced consultants have extensive practical experience in this area and can help you choose the most appropriate path to market based on your specific circumstances.     If you would like to discuss this issue with us then please contact us on 00353 52 61 76 706 or complete your details below.  Regulatory strategy development is pivotal to the success of every pharmaceutical product and our experts can assist you in the development of your strategy.