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.Continue reading “Medical Device”
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.Continue reading “GMP/GDP”
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.Continue reading “GVP”