Services - Regulatory

COMMUNICATION WITH DRUGS CONTROL DEPARTMENT AND OTHER FOREIGN REGULATORY AGENCIES ON TECHNICAL & LEGAL ASPECTS

We shall assist in drafting letters and replies to notices to Drugs Control department and various other Regulatory Agencies, worldwide, on matters involving Technical as well as Legal matters with regards to Drug products.

The communication from Drug Regulatory agencies must be responded with technical and legal aspects reflecting regulatory compliances in every sentence without any legal snags. Our Consultants, possessing pharmaceutical as well as Legal qualifications, with more than 25 years of experience in Pharmaceutical Operations can handle any situation of non-conformities reported or noted by the Regulators and can also suggest suitable solution to comply with the non-conformities. We also facilitate representation before Drugs Control Authorities, or any authorities, on behalf of the manufacturers/companies.

This is a unique service provided by our Consultancy Services for the benefit of the Pharmaceutical Industries.

COMMUNICATION WITH OTHER REGULATORY AGENCIES UNDER VARIOUS ACTS- LABOUR DEPT, POLLUTION CONTROL DEPT, FACTORY INSPECTORATE, INCOME TAX, COMPANY REGISTRAR, GST etc

We shall assist in drafting letters and replies to notices to various Regulatory Agencies issuing licenses to operate and run a Pharmaceutical Industry. We shall also suggest suitable solution to comply with the non-conformities reported by the department officials ensuring 360 degree compliance under every statutes required to be complied with a Pharmaceutical Formulation unit. This includes facility licenses as well as various licenses for marketing and export of Pharmaceutical products.

The services include drafting of letters/memos under various Labour acts for internal circulation, replies to show-cause notices issued by various Regulatory agencies, facilitating representation before Regulators on behalf of the manufacturers/companies etc