To provide the right scientific advice at the right time to ensure a successful regulatory outcome. Less deficiencies ensures faster approval.
To provide novel solutions to problems faced by clients.
To work at all times with professionalism, integrity and confidentiality.
Dr Ketan Vora has a number of years of experience working as a pharmaceutical assessor within the UK regulatory agency, the MHRA. Ketan was responsible for the regulatory review of numerous small molecule submissions and hundreds of post-approval variations. This included National assessments and European assessments via the mutual recognition (MRP) and decentralised (DCP) procedures. Other roles included scientific advice meetings, introduction of BROMI Simple Applications and assessing readability studies (User Testing).
Since leaving the MHRA, Ketan has consulted for start-up companies all the way up to multinational companies providing strategic, regulatory and business advice tailored to suit the needs of each individual client. Ketan has also had the opportunity to act as an independent consultant for other national regulatory agencies outside of Europe.
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