Regulatory Affairs Documents
Regulatory Documentation Support
We provide a comprehensive list of services for the pharmaceutical and healthcare sectors, including global legalization services and submissions and filing in both India & overseas markets.
Our service for Regulatory documents was initiated in the early ‘90s as a result of the increasing level of services requested by our existing client base. In addition to providing a comprehensive external legalization service, we also provide both external and in-house support for our clients’ global submission of documents to the relevant Health Authorities.
Legalisation
We process 1000’s of documents for legalization on a weekly basis, and a significant proportion of this volume are CPP, GMP, M/L and pharmaceutical related documents (e.g Price Certificates), which we either receive directly from the manufacturer/exporter directly or via third party agencies.
Depending on the market concerned, we evaluate the ‘optimum’ legalization route in terms of compliance, speed and cost to deliver the best possible service to our customers.
Typical applications with which we deal on a daily basis include:
- CDSCO (Central Drugs Standard Control Organization)
- Ministry of Agriculture and Farmers Welfare
- CGPDTM (Office of the Controller General of Patents, Designs and Trade Marks)
- TRAI (Telecom Regulatory Authority of India )
Please contact our Sales team on [email protected] to discuss your Regulatory Affairs Document needs.
