REGULATORY AFFAIRS & PROJECT MANAGEMENT SERVICES
Regulatory affairs play an integral role for a fruitful product cycle. Successful launch of any product in the market invariably depends upon the successful approval of the product at the concerned regulatory authority. An expert team of regulatory scientists specialised in providing wide range of services for registration of various agro and fine chemicals in India and EU. Working together with consultancies in other parts of the world enable us to offer the registration of all kind of chemicals in Southeast Asia, Japan, South Korea, Canada, China, USA, Central and South America.
Key services
- To prepare a regulatory strategy.
- Thorough analysis of substances and products.
- Decision on the regulatory framework.
- Data gap analysis.
- Advice on data requirements.
- Preparing the testing strategy.
- Selection of appropriate CRO for placing different studies.
- Advice & support on Classification & Labelling.
- Support to prepare MSDS.
- Organizing dossier preparation and submission.
- Liaison with the Regulatory Authorities.
- Post-submission support to achieve the intended registration.
- Answering deficiencies or defending cases at the authorities.
- Keep updated information about the changing regulatory policies.