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India's Leading consultants for 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.
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.
Has 4 APIC certified auditors and team of experienced personnel.
Our mission is to become India’s most admired company providing Quality, Regulatory (compliance),Training, Gap analysis and Project consulting services to the API, Formulation and Biotechnology Companies.
We aim to provide peerless service to our clients and do whatever it takes for the complete satisfaction of our customers.
To provide cost effective services to the clients for up-gradation of facilities, quality management system, regulatory submissions and inspection / approvals to comply with the international regulations.
To keep abreast with latest regulations & trends in pharmaceutical compliance regulations including data integrity.
To help its client in resolving complex regulatory issues.
We have an enviable track record of more than 110 successful USFDA/EDQM/COFEPRIS /MFDS (KFDA)/Health Canada and other International Regulatory Inspections/approvals & Greenfield and upgradation projects.