Pharma – biotech regulatory service

Regulatory strategy assessment
The correct regulatory strategy is absolutely critical to the success of your project/business, and you will be pleased you took AdAct Medical consultants advice in developing your strategy. The regulators are a powerful group that control access to the markets, but they are also a scientific, approachable group that operate within clear boundaries and guidelines. Knowing how best to go about bringing your technology to market will have a powerful impact on your business as you develop your technology.

Briefing book preparation
Once you have a strategy and plan we always recommend going to the regulators and getting them to rubber stamp it, this is particularly important when your going out fund raising, this process stops investors putting in market specific studies into the plan and diluting your equity based on the expense of conducting them. In order to get this definitive position you will need a briefing book to support your position and the meeting and you will be happy that AdAct Medical consultants have prepared it for you, with many years of experience and many such meetings under our belt we know how to go about preparing the documentation for you, to ensure you get the best results form the process.

Regulatory meeting arrangement and support
As discussed above, a scientific review meeting with the regulators can be a powerful tool in your business development arsenal, but only if its undertaken correctly and supported fully, AdAct Medical consultants have the experience to manage this daunting process for you to ensure that you achieve all your objectives and form a strong working relationship with the regulators.

Full early stage regulatory documentation
Never underestimate the documentation needed to get your product into man: briefing books, IMPD (Investigation Medicinal Product Documentation), ethics applications, protocols, investigator brochures, CTA (Clinical Trials Applications). But, the good news is there are standard formats and economies of scope to be achieved so use a company that you can trust.

Take at look at the services we offer – they can make a huge difference to your project.