Mr. Pradeep Karatgi

Dr. PradeepMr. Pradeep Karatgi, Founder IDRS Labs
Dr. Pradeep Karatgi is the Co-founder and Director at IDRS Labs Pvt. Ltd., Bangalore, India. IDRS is a specialty formulation and analytical research organization with contract research as its primary business focus( As part of IDRS, Pradeep is involved with multiple pharmaceutical organizations globally in QbD based development programs in the area of formulations and APIs. Prior to founding IDRS, Pradeep was working at Dr. Reddy’s Laboratories Limited, Hyderabad, India as Associate Director, CPS formulations (CPS formulations is a wing of Dr. Reddy’s that caters to external customers) and was responsible for leading multiple teams of scientists for enabling product development. Pradeep has about 12 years of experience in formulation research and development, process characterization, scale-up and clinical supplies manufacturing. His experience ranges from developing formulations for NCEs, NDAs and ANDAs. His key achievement has been successful development of two major NDA products. Pradeep has also led the product development and filing of multiple ANDAs with USFDA using QbD / DoE principles. He has been recognized with various awards on multiple occasions for excellent contribution at Dr. Reddy’s. Pradeep has several patent applications, peer reviewed publications and presentations. He has also authored a book chapter. Dr.Pradeep has been an invited speaker at various venues. One of his international publications – in the journal AAPS Pharmaceutical Science and Technology is credited as being one of the top five highly downloaded articles and is appreciated by the publishers as well. Previously, Pradeep was also employed at Ranbaxy Research Laboratories, Gurgaon, India and Torrent Research Center, Gandhinagar, India.

IDRS generates value by developing innovative drug research solutions for its clients (Generics & Innovator pharmaceutical companies world-wide). We provide contract services primarily in the areas of drug product and clinical development. We have hands-on expertise in speciality areas such as Quality by Design (QbD) and Design of Experiments (DoE) ; Biosimilars and various niche formulation technologies.

IDRS offers two types of services:
1. Contract Formulation and Analytical Development Services
Our fully equipped laboratory, based out of Bangalore, India, will be operational by February 2014. IDRS will offer formulation development services for both cytotoxic and non-cytotoxic molecules. Our experience spans NCE and Generics development for global market registrations – including USA, EU, APAC, Japan, Russia, Brazil and MENA regions.

2. Consultancy services
We believe we can significantly accelerate your development timelines and time-to-market by using our expertise and successful track record in QbD, DoE and Biosimilars. For example, we have successfully developed multiple ANDA/NDA submissions based on QbD/DoE methodology. We also have know-how regarding QbD-based API development. Based on our hands-on experience, we offer the following consulting services:
– QbD and DoE – for formulation, API & analytical development.
– Biosimilars – Consultancy in CMC, Preclinical and Clinical development.
– Formulation & Analytical Development Consultancy

IDRS Strengths – Distinctive knowledge and capabilities
– IDRS technical leaders have been invited speakers at international industry conferences on QbD and Formulation Development. They have published several scientific papers in peer-reviewed journals and have many patents granted/filed.
– They have played a pivotal role in the clinical development of multiple biosimilars launched by a leading Indian pharmaceutical company

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