Director’s Desk

Director’s message:
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”.

Testimonials :

Dr. Manjusha Rajarshi
Managing Partner, Regulus Health Care

“I know Anagha as a dynamic, sincere and hard working young professional. She is very open, direct and objective in her approach. Her vast experience in the industry and practical insights are very helpful for the clients and knowing her she shall never leave any work unfinished and pending. My best wishes always to Anagha and her wonderful team….”

Ms. Praveena Manglorkar
Head Technical Agreements CIPLA LIMITED Exp: 26 years

I know Ms. Anagha Maharrao for more than a decade. We are very good friends. Anagha is a great human being and a wonderful professor. She is a source of immense knowledge and her enthusiasm for the topic and tremendous expertise in Regulatory Affairs is highly appreciable .
Famous scientist Darvin said SURVIVAL OF THE FITTEST.
Yes it is true but we have to add one more line with time passed by.

Today’s world is a world of changes, upgradation .There is a constant process of knowledge getting upgraded. . We need to update our knowledge if we have to remain in stream otherwise we will be left behind.

IPM courses started by Ms. Anagha are boon to regulatory professionals & for people who are experts in other areas like formulation development, Quality Assurance , Analytical Development and Clinical Research. The courses offered by IPM exposes the attendants to new modes of thinking and evaluating various aspects of regulatory affairs.

IPM courses are designed as per the industry needs and they cover all practical aspects along with updated regulations existing in US and EU both for API and Finished products.
Anagha ensures that the basic fundamentals of guidelines are well understood by each and every student.

The members of teaching staff identified by Anagha are experts in respective fields and are providing indepth knowledge of all the latest developments, additions or deletions as far as laws of world of Regulatory affairs,Patent Laws, Quality management and several other fields are concerned.

I feel fortunate to acquire new knowledge through the course of IPM.
With immense gratitude , I thank Ms.Anagha for introducing us with this vast field of knowledge through IPM with comfort and most approachable manner”.

Dr. Madhu Gautam,
Head of Sales, India and Middle East, Hovione

I know Mrs Anagha Maharao since 1999 when I was first introduced to Calyx. Her main portfolio was to look after Regulatory, cGMP Training, CTD / DMF Filing, internal, customer and authority driven Plant Audits. First as R & D and later as Business Development activities in which I was involved, brought us closely to work together and we became good friends too. She is a perfect example of self motivator .. achieve success thru sheer determination, dedication and hard work. I have seen her growing up to QA head from a very humble background, attended many plant audits, international events, seminars and now a woman entrepreneur running her own institute. I am sure she will be one of the examples of successful Women Entrepreneur who made it from scratch and will have a leading training institute of repute.

To summarize my impresion about her:

  • Aptitude for innovation
  • Noble values
  • Ambitious Generous
  • Honest
  • Ample knowledge of pharma regulatory affairs

Dr. Ramkee Iyer,
Vice President R&D API FDC Limited, Mumbai

It gives me great pleasure to write about Ms.Anagha Maharao who has been working with FDC in the capacity of a consultant. She is sharp, resourceful, meticulous and to the point. She is organized & comes well prepared for the meeting.
Here are some of the highlights that have been listed below which has helped the RA department of FDC.
Revision of CEP dossier as per the new European (EDQM) guidelines
Preparation of report for Genotoxic Impurities along with literature references which are useful for EU dossiers
Discussion and guidance for responding to the MHRA queries for APIs
Guidance on routine customer requests and handling variations in some existing EU registrations for in-house formulation
Overall improvement and thinking skills of the RA department