Drug regulatory services india - Delhi

We are an ISO 10002:2004, ISO 9001:2008 Company and one of the leading and well-established consultancies of the country. We work mostly in the medical and pharmaceutical domains. Our clientele consists of numerous local and international manufacturers, distributors, importers, etc. We assist them by liaisoning on their behalf with all sections of the state and central Drugs Department for submission of applications, obtaining various permissions & approvals, obtaining clinical trial permissions, etc. We also look at the drug regulatory rules from a perspective of customs laws to avoid unnecessary complications for the client while importing their products. For imports, we assist the client in facilitating import of goods with services like applying for import permits, customs clearances, licenses, documentation, etc.

As a company, we have one of the largest number of briefs on Diagnostics & Medical Devices Regulatory work. We combine this with our in-depth knowledge of drug regulations and help our clients in preparation of pamphlets, brochures, etc. and ensure they are as per the guidelines prescribed by various government departments. Besides this, we also help our clients in preparing dossiers for obtaining Manufacturing Licenses, GMP systems, etc. from respective State Drug Controller & Regional CDSCO.

Besides the Drugs Department, we also liaison with Department of Animal Husbandry, DGFT, FSSAI, CDSCO, Ministry of Science & Technology or any other Govt. Departments as per the need of the client.  We are also into consultancy of getting accreditations such as NABH to hospitals, NABL to laboratories, and other accreditations in the field of healthcare.

We also have channel partners in other consultancy fields and are associated with them for providing their services. A few of these services are for providing Company Secretary, Chartered Accountants (Audit and Accounting work), professionals for doing market surveys, HR consultants, CE Certification Consultants, ISO Accreditation Consultants, professionals for organizing clinical trials and other such services as per the requirement of the client. We ensure 100% compliance with all laws of the country including international laws like FCPA.

We have presence in major cities of the country and are fully equipped to undertake any pan India project.

We believe in undertaking projects with dedication and completing it to perfection and delivering on time to the satisfaction of the client. This is the reason why our clients have time and again shown faith and trust in us and placed us way ahead of our competitors.