Pharmaceutical Consultancy Company in Mumbai, India| Pharmadesk

Discover Pharmadesk

As Generic Pharmaceutical industry continues to mature and penetrate new areas, the regulatory and competitive landscape becomes more challenging. Every stage of the product life cycle needs very specific expertise and detailed understanding. Bioequivalence (BE) being one of the most important aspects of the generic product development, has always gained significant attention from the Regulatory Authorities throughout the world. Pharmadesk is one of the leaders in providing end to end solution for all the BE related requirements of generic pharmaceutical companies. It supports complete BE study requirements, conduct and management aspects through a portfolio of well-designed services. We work with a well-defined goal: To work closely with our clients and respective service providers as a ligament ensuring that the projects are delivered within stipulated timelines at accurate price and being technically competent to face regulatory challenges. After years of contribution in various leading Generic Pharmaceutical companies, Dr. Ravindra Bhavsar identified the specific needs of product developers, which need expertise beyond what typical CROs can offer. The idea of Pharmadesk germinated with this thought and was started in the year 2011. During the last 07 years, we gradually became a solid platform for some of the most complex generic developments in most of the developed markets by providing BE related support and are driven by a dedicated team of more than 25+ like-minded industry experts. Pharmadesk now boasts the capability to support the Bioequivalence requirements for various dosage forms ranging from oral solids to complex injectable products and markets. We have been successfully delivering solutions to many multinational generic companies focusing on USFDA, MHRA TGA, Canada, Brazil and many more submissions.

What Do We Do?
Why We Exist?

We provide consulting & complete project management services to generic pharmaceutical companies for Bioequivalence and related activities. We have been supporting Generic Pharmaceutical companies in Product feasibility assessment, CRO selection, Medical writing, Project management for BE study, BE study monitoring, Failed BE study analysis, IVIVC and Regulatory support regarding BE studies. Our strength is our technically sound team who have been constantly delivering the projects within time. We provide a deep insight to your generic product development and ensure a risk mitigation strategy is in place for bioequivalence program to save millions of dollars for your organisation. With 25+ experienced & qualified team of Project Managers, Clinicians, Pharmacologists, Formulators, QA, Regulatory, Analytical, Bioanalytical experts as well as Ex—MHRA Consultant on Board, Pharmadesk takes complete ownership of your Bioequivalence studies and ensures they get completed efficiently & successfully by carefully evaluated & selected CROs in India. With an experience of handling more than 380 successful BE studies submitted to EU and USFDA regulatory authorities and based on the cumulative experience of multiple products for multiple markets, we have well-defined processes in place for every activity in the Bioequivalence study cycle. We assign a dedicated project manager for every project to ensure complete attention is given to individual projects.

Dr. Ravinder Bhavsar is the Founder, Director and Head of Pharmadesk and has vast practical experience in supporting various companies as an Assistant Director for Bioequivalence, Preformulation; Analytical Head at Lupin Research Park and supporting personal for establishing Glenmark BE centre. Based on several years of his experience, he realised there is a need for CRO with a team of subject domain expertise to solve the real challenges, problems of growing pharma companies, understand formulation & development issues equally and have great BE and analytical understanding which is lacking in most of the existing CROs.

He has also witnessed that lack of subject domain expertise team in the CROs is causing growing pharmaceutical companies to face challenges, financial loss and product failures during product development. Unfortunately, these issues were not being handled and are considered beyond the scope of a BA/BE CRO resulting in a huge gap which needs to be fulfilled.

Since our inception, we at Pharmadesk have realized the need & support of growing pharmaceutical companies in their generic product development programmes and adopted a 'consulting & solution oriented' approach and were never interested in building 'typical' Project Management Company.

There are various areas which need the support e.g.

In securing and strategizing biostudies
In deciding if pilot study is really needed or not.
What changes is required in formulation

In increasing bio success rate or to perform In Vivo-In vitro correlations
In performing failed biostudy investigation
Feasibility in analyzing bio challenges when product is selected for development.

And many such things!

With the expert in-house team, we started developing, establishing systems and procedures even for smaller tasks eight years ago with the aim of achieving successful bio studies, minimising study time, improving efficiency with better control and zero observations for any of our projects.

We have successfully delivered more than 400+ projects across various geographies including Australia, North centre, South America to Europe, Canada with more than 98.86 % proven success track record. Not a single study has been rejected by EMEA/USFDA so far. Over the period, our Project Management tools, systems & procedure were evaluated & appreciated by our clients, which helped us to get UKAS certification by British Government recognized body. We are also a member of Association of Clinical Professionals (ACRP) USA and a lead member of Royal Society of Medicines, UK. To meet customers' varied requirements, in 2016 we have customized our services into different packages such as “BioVigil” for BE monitoring, “ONTRACK” for BE studies project management and “Augment” for handling complex study designs, sample size estimation, failed BE study investigations etc to help them to analyses and choose the best and decide on go- no go decisions. There are more services which are explained in details under "Service" section of our website. We invite you to visit Service and explore more about it or explore Interactive "Challenge" section to to verify if you face any such similar challenges. We look forward to know more challenges from you while planning for your bioequivalence study and associating with you to offer successful solutions for it.

Our Journey

2011

Incorporation of Pharmadesk as Private Ltd Company

2012

1st US FDA and EMEA BE Study Submission done successfully
Invited by Panama Regulatory for setting up and guiding BE Studies
Completed 40 BE Studies

2013

Completed 56 European Submissions
1st TGA BE Study Submission
Introduced Mediblog, a standalone medical writing service as per demand
130 projects completed successfully

2014

Completed 89 European Submission
Initiated standalone site audit service; Endorse
Audited one of major CRO's

2015

Implementation of Project Management Software tool
First to file Iron Sucrose submission for US FDA
Completed 1st BE Study project for Health Canada
18 BE study projects for TGA delivered successfully
1st NDA project for US FDA accomplished
Introduced new standalone service Augment; support services like failed BE study investigation, due –diligence

2016

105 US FDA Submissions,
First to file Iron Sucrose Submission to Europe
Received accreditation from UKAS, a British government recognised body
Started first F& D project,
Development of a marketing platform Exhimeet initiated
10 successful BE submission to Health Canada
Received Certification from Association of Clinical Professionals (ACRP)
Successfully completed 380 projects

2017

First to file Propofol Submission,
Initiated the process development for data integrity audit (first company to start off)
Filed Sponsor Project in India
First to file Propofol Submission to Brazil

2018

Successful conduction of Propofol study for ANVISA submission
Launch of "CRO Method Library" through our website, we are only one to launch the same in world
Many more to come

Our Founder Director

Dr. Ravindra Bhavsar

Managing Director and CEO

Dr. Ravindra Bhavsar has more than 20 years of experience in the area of Bioequivalence. After completion of his Ph. D. in Analytical Chemistry from Mumbai University, he was associated with leading Pharmaceutical companies and a CRO. He has served at Lupin Pharmaceutical as an Assistant Director where he was responsible for in house Bioavailability and Bioequivalence Centre during early development of Lupin bio Centre. He has also setup Bio analytical department at Glenmark Pharmaceutical supporting USFDA submission for Glenmark Pharmaceuticals. Prior to Pharmadesk, he founded and was heading Synapse Labs Private Limited, a CRO based in Pune, India. After establishing Synapse and taking it to considerable heights he decided to exit and utilize his time in consulting. During his long association and exposure with Pharmaceutical and CRO industries, he identified a gap in understanding & knowledge of each other's domains between bioequivalence, formulation development and regulatory teams. He decided to fill this gap, to mitigate the risk of bio-failures and this lead to conceptualisation of Pharmadesk.

Our Consultants

Dr. Ravishekhar Kasibhatta

Dr. Ravishekhar Kasibhatta has more than 20 years of experience in bioequivalence. After completion of his Ph.D., he is working with various CRO and Pharmaceutical companies. He is on the board of one of the well-known Japanese and American organizations. He is also invited as a guest speaker in various national and international conferences.

Dr. Sandeep Sharma

Dr. Sandeep Sharma has more than 19 years of experience in bioequivalence. He has worked with various well known CRO and Pharmaceutical companies. Currently he is director (bioanalytical) Jubilant Clinsys Ltd. He is on the board of well-known international pharma company. He is also speaker in various national and international conferences and workshops.

Mrs. Maharukh Rustomjee

Mrs. Maharukh Rustomjee working from last 32 years in various companies as an employee and as an entrepreneur in the recent 17 years. Currently she is managing partner at Amaterasu Lifesciences LLP. She is also founder director of Rubicon Research Pvt. Ltd. She is also speaker in various national and international conferences.

Dr. Anupama Ramkumar

Dr. Anupama Ramkumar has been a part of the Clinical Research Industry in India since its early days and helped set up and built two GCP compliant Clinical Pharmacology units. She was one of the first Principal Investigators doing first in human studies in India. She has represented and faced through successful regulatory inspections including USFDA, AFFSAPS, WHO, ANVISA and many others.

Dr. Hardeep Wadhwa

Dr. Hardeep Wadhwa with 25 years of experience of working in pharmaceutical Research and development, spawning innovation on one hand while ensuring its manufacturability on the other; by expertly managing all the steps of the process in the middle. His endeavours have led to valuable patents and significant business advantages for his clients.

Mrs. Pradnya Bagade

Mrs. Pradnya Bagade has more than 20 years of experience in bioequivalence. After completion of her Ph.D, she is working with various CRO and pharmaceutical companies. She is on the board of couple of national and international organizations. She is also been speaker in various national and international conferences and workshops.

Mr. Mangesh Patankar

Mr. Mangesh Patankar has more than 20 years of experience in bioequivalence. After completion of his Ph.D. he is working with various CRO and Pharmaceutical companies. He is on the board of organizations and institutions. He is also a speaker in various national and international conferences.

Dr. Chaitanya Saxena

Dr. Chaitanya Saxena has more than 19 years of experience in bioequivalence. He is working with various CRO and Pharmaceutical companies. Currently he is CEO of Shantani Proteome Analytics. He is also speaker in various national and international conferences

Dr. Sasi Kumar Menon

Dr. Sasi Kumar Menon has more than 20 years of experience in bioequivalence. He is working with various CRO and Pharmaceutical companies. Currently he is working as an Assistant Director of Therapeutic Drug Monitoring Laboratory. He also owns a good experience of working for more than 20 clinical trials on Topical formulations in the position of study Director and as an Author for various publications. Conducted more than 25 acute and subacute toxicity studies for DCGI (India).

Discover Pharmadesk...

Why we exist & What we do