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Innovative Drug Research Solutions

About Us

IDRS LABS Private Limited (“IDRS”), a company founded by experienced scientists from the pharmaceutical industry, was established in October 2012, with an immediate goal of offering technical consultancy services to pharmaceutical organizations; a mid-term goal of operating as a Specialty Research Organization catering to pharmaceutical companies across the globe. In the last 2 years, IDRS has been a front-runner in India in imparting the knowledge and training on quality-by-design (QbD) concepts to scientists in pharmaceutical industry.

 

Our Facility

What we do

Drug product development

IDRS offers formulation and analytical drug product development services for sterile dosage forms, oral solids, oral liquids development for cytotoxic and non-cytotoxic products from its advanced ~12,000 sft facility based out of Bangalore, India.

Formulation development

  • Pre-formulation profiling and druggability assessment
  • Generic formulation development
  • Formulation Development for FIH studies and various clinical phases
  • Preclinical Formulation Development
  • Formulation Development for Life Cycle Management(LCM/NDDS)
  • Pediatric Formulation Development
  • Veterinary Formulation Development

Analytical development

  • Analytical method development for API and drug product
  • Method validation for API and drug product to support DMF/IND/CTA/NDA/ANDA applications
  • Stability studies to support development and regulatory fillings of API and drug product
  • Solid state characterization for ‘as is API’ and in drug product.
  • Cleaning methods for drug products
  • Method transfers.

Clinical development

IDRS will work with its partner CRO (or with a CRO selected by Sponsor, if any) to execute End to End Clinical Trial.

Project Management

  • Dedicated project management team to manage all projects and ensure on-time delivery.
  • Periodic customer interactions by an independent Key Account Manager  to resolve customer concerns.
  • Complete project tracking through MSP and issue escalation at the right time.

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Winner of “Indian Leadership Award for Industrial Development” for the year 2014 - awarded by AIAF, Delhi, India

WHAT WE DO

MANAGEMENT

Shivkumar Madki

Shivkumar, a trained Clinical Pharmacist, brings significant experience in core clinical research. He has been involved in conducting multiple clinical trials in various indications for India and global registrations. He has experience in conducting Phase-II to IV clinical trials for small molecules and bio-similars.

 

Mahendra Joshi

Mahendra Joshi brings significant experience in solid and liquid oral formulation development. He has experience in setting up the formulation laboratory and in establishing the systems for preformulation and NCE product development. He has successfully developed drug products for global pharma majors to support IND, CTA, NDA and ANDA fillings.

Yogesh Bhandari

Yogesh is an entrepreneur who has been a part of many successful ventures in the pharmaceutical industry. He brings substantial experience to IDRS in areas of Finance, Business Strategy and Operations (including logistics and supply chain management).

Pradeep Karatgi

Pradeep brings significant expertise in formulation research and development, process characterization, scale-up and clinical supplies manufacturing. His experience spans developing formulations for NCEs, NDAs and generics.