It is rightly said that “You are your greatest asset. Put your time, effort and money into training, grooming, and encouraging your greatest asset”
In today’s pharma world, the regulatory agency puts the burden on firms to establish comprehensive procedures that not only specifies how personnel will be trained, but also outlines the record keeping requirements for the program.
Thus, the stringent regulatory standards have forced pharmaceutical organisations to change their functions and also to ensure that their employees are in sync with developments across the world.
IPM aims benefitting not only the brilliant young minds but also the pharma professionals aspiring to build a successful career in the pharmaceutical industry.
Having faced many regulatory inspections, made me aware of the intricacies of the entire inspection process – data integrity, risk based approach, handing failures etc. This triggered the birth of GMP consultancy cell of IPM which focuses on helping the organizations aiming to market their products in regulated & emerging markets by guiding them right from the nascent stage of preparing documents till the successful achievement of approval.
When it comes to filing a DMF or dossier, time and expertise play a crucial role. Documents generated at each step right from R&D to final product packaging have to meet the stringent norms of regulatory authorities. Regulatory submission is a very critical process because of its ever-changing nature. With this in mind, IPM and its team of erudite regulatory experts vouch to aid pharmaceutical firms on all aspects on regulatory submission for API and formulation.Even after product approval, we have to maintain DMF/dossier in compliance with lifecycle management guideline as per ICHQ12.
Here at IPM, we believe in “fostering excellence in the pharmaceutical field by catering to regulatory, GMP and training needs”.