Incorporated in June 2002.
A leading provider of Quality, Regulatory and Project consultancy services for compliance to USFDA, EDQM, EU GMP, MHRA, TGA, MCC, MFDS (KOREAN FDA), COFEPRIS, HEALTH CANADA. PMDA and other regulatory agencies for API, BIOTECHNOLOGY and FORMULATIONS manufacturing pharmaceutical companies.
It has reached an enviable position assisting pharmaceutical companies in upgrading QMS, Facilities, Regulatory submissions and Inspection / Approvals.
Has also guided in the preparation and / or review of Regulatory Submissions – DMFs, EDMFs. CEP Dossiers.
Has an exceptional ability to provide solutions to multi-disciplinary FDA and EU GMP / EDQM and other agency’s regulatory concerns regarding Facilities, QMS, Regulatory Submissions and Compliance.
We assist in overcoming DMF deficiencies, reply to 483 observations (USFDA) and audit observations of other regulatory bodies through a team of qualified and experienced Quality & Regulatory professionals.
Third Party Auditors for API / Intermediate, Formulations and Fermentation facilities to a number of European Companies and Mexican company in India, Europe, Asian countries and US, as per ICH Q7 GMP guidelines, EU GMP Part I and Part II guidelines.
We have an enviable track record of more than 135 successful USFDA/EDQM/COFEPRIS /MFDS (KFDA)/Health Canada and other International Regulatory Inspections/approvals & Greenfield and upgradation projects.
