We provide scientifically based strategic and operational support and advice to companies and academia from early research throughout the product lifecycle. 

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Medical Device

Offering strategic and regulatory advice to our clients with the aim to navigate the regulatory landscape with the complete product lifecycle and business opportunities in mind. By including the regulatory aspects early on in the project, the path to market access can be influenced and time to market minimized.

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It is challenging to find the right level of quality oversight and quality system detail. Good practise dictates that your efforts should be proportionate with the complexity of your operation. 

At RegSmart we understand that the quality of the product is based on scientific data and rationales, we understand that a solution must be fit for purpose. 

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RegSmart will be able to support clients to fulfill post-approval pharmacovigilance (PV) requirements, offering strategic advice in development of your pharmacovigilance systems, including pharmacovigilance System Master File (PSMF), to obtain a system that is fit-for-purpose based on your needs and in compliance with regulatory requirements.

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