IGRS is an Association of highly skilled Professional Regulatory Consultancy service providers in Dossier Compilation to industries like manufacturers of Pharmaceuticals, OTC, Generics, Clinical, Biotechnology, Consumer Healthcare, Nutraceuticals, Herbal, Medical Devices, Food & Beverages, Confectionery, Cosmetics, Veterinary, etc. Our focus is to work in close collaboration with our clients to provide Innovative and Cost effective quality solutions to help maintain their competitive advantage from early product development right through to licensing, to the market and beyond. We work with equal success in partnership with large multi-nationals, small start-ups, biotech companies, CROs, etc.

We can provide services in the following ways:
  Innovator Sample Procurement
  Product Development, Sourcing
  Manufacturing & Marketing, Sourcing
  Batch Validation, Analytical Method Validation
  Pharmacovigilance
  Bioequivalence Monitoring
  Clinical Writing, Expertise knowledge regulatory and scientific knowledge
  Efficacy & Toxicity Studies
  Compiling large regulatory application for submission in different countries
  Expertise knowledge and support in terms of local regulatory authority
  Expert solutions to FDA queries
  Access to scientific and technical resources
  Audits
  Formulation and implementation of regulatory strategies on a global level

We also do the gap analysis of dossiers, product development CTD dossiers for regulated markets. We offer complete support for preparation of necessary document and registration of products with FDA and answering post submission queries.

IGRS was started by Bharathi Ramesh in 2010, who has over two decades of wide and varied experience in Regulatory Affairs in the pharmaceutical industry.