Regulatory services

Rapid and successful registration of the active substances and products is the key to achieving economic success. We provide services in data generation for registrations of products as per contemporary regulatory guidelines. We have a GLP, NABL compliant facility. Also, we are an approved laboratory by Central Insecticides Board-India, for data generation as per Indian Regulatory requirements.

Through 10+ years of research and learning, Ross has developed expertise to provide guidance to our sponsors for various Regulatory requirements. We keep ourselves updated as per the contemporary regulatory guidelines and our experiments and reports are designed in such manner to fulfill the specific regulatory needs.

Registration of products with CIB

We provide registration services of pesticide products in India under various categories of The Insecticides Act 1968 for Import/ Indigenous manufacturing of technical material or formulations. It includes:

  • Strategy and planning, performing data gap analysis
  • Dossier preparation and submission
  • Me-too registrations for indigenous manufacturing
  • Export only applications
  • Endorsements for label claims, packaging or other changes related to import source/manufacturer
  • Data generation as per OECD guidelines for registration requirements outside India
  • Quality Assurance compliance handling of misbranded samples

 

Registration of products with FDA

Registration of products (Drugs, cosmetics and disinfectants) under Drugs and Cosmetics Act. This includes:

  • Data generation- Preclinical and Clinical toxicity studies
  • Design and execution of Clinical trials
  • Data collation, Dossier preparation and submission
  • Obtaining registration