IDRS LABS Private Limited (“IDRS”), a company founded by experienced scientists from the pharmaceutical industry, was established in the year 2012, with an immediate goal of operating as a Specialty Research Organization catering to pharmaceutical companies across the globe; with a mission to offer solutions of world-class quality with a strong emphasis on confidentiality, reliability and customer delight.
IDRS operates from its product development facility of 25,000+ sft based out of Bangalore, India and offers stand-alone contract services for formulation, analytical & clinical development. IDRS is working on several complex and varied generic formulation development projects intended for filing in regulated markets (Europe and USA) with customers based out of USA, Europe, China and India. On their individual platform, IDRS’ Management has a proven track record, having developed scores of products for key markets such as USA, EU, Japan, Brazil, Russia, India, South Korea and RoW markets. IDRS has hired experienced and trained technical personnel in various functions, having worked on several complex products in their professional career. Currently about 50 personnel are employed at IDRS, of which about 43 belong to different technical functions. IDRS scientists are well known in the industry for their expertise in areas such as QbD (Quality by Design), DoE (Design of Experiments), as well as development of biosimilars and have several scientific publications in peer reviewed journals and international patents. IDRS has been the front-runner in India to train pharmaceutical scientists on QbD. IDRS has provided consultancy services in development of several complex generic products (with different dosage forms) with its clientele spanning USA, Europe and India. IDRS experts have delivered about 10 invited lectures pertaining to QbD across various industry and academic conferences in India. IDRS experts have also extended their services as a part of the expert panel on coming up with an Industry Advisory Report (IAR) on Knowledge Management by LASSIB Society.
Quality by Design (QbD) and Design of Experiments (DoE):
USFDA and EMEA now expect dossiers for both generics and NCEs to be developed based on QbD principles. Because this is a relatively new requirement, there is a large supply/demand gap in the market regarding finding experts and CROs with hands-on experience in QbD/DoE. IDRS is uniquely positioned to take advantage of this supply/demand gap. IDRS experts have a proven track record with QbD – both in internal projects as well as for global clients. They have successfully filed several products in regulated markets such as USA using QbD/DoE. Further, they are industry-recognized experts in this area; having been invited speakers at several industry conferences on QbD. And have relevant publications in peer-reviewed journals in QbD based drug development.
Cytotoxic Product Development:
IDRS facility is well equipped to handle product development for cytotoxic compounds in solid oral and injectable segments. The systems and processes are appropriately designed to enable development of cytotoxic compounds. The scientific team at IDRS is well trained and experienced in development of cytotoxic products. Coupled with their core competency in formulation development of anti-cancer compounds, IDRS also possesses substantial experience in running oncology clinical trials.
NCE product development:
Few pharmaceutical organizations in India, engaged in contract research, possess extensive experience in product development of NCEs (New Chemical Entities). IDRS personnel have significant experience in development of drug products for NCEs and have worked on several INDs at various stages of development, including first-in-human (FIH) dosage form development. IDRS also has substantial experience in conducting developability studies (preformulation studies) for enabling candidate selection.