Regulatory Affairs Service

• Service Location: All India
• Service Mode: Online/Offline
• Duration: Depends On Scope of Work
• Type of Service Provider: Regulatory Intelligence Services

Are you in search of a trustworthy name that can provide dependable solutions for regulatory affairs? If the answer is yes, then we are the right place to approach. Ours is a team of professionals who work together to deliver the best in class solutions. With our services, we provide dependable solutions related to dossier, DMF, etc.   Our regulatory services cover the following : Dossier Compilation Dossier in ACTD/CTD Format Preclinical and clinical Overviews / Summary writing based on literature search / Published studies / articles from journals Dossiers for ASEAN and ROW countries in ACTD/ as per country specific format, for any dosage form Dossier reformatting to CTDtaking up gap analysis of existing dossiers in line with current requirements Product information update (SmPC, PIL and Labeling). Preparation of Drug Master File and Certificate of suitability (open and closed part) Bioavailability and Bio-equivalence studies: I co-ordinate Bioavailability / Bioequivalence / Clinical Trial Studies / Pre-clinical trial studies through well-established study centers for various dosage forms

We offer- • Quality System Certification & Documentation: Preparation, Maintenance, guidance for FDA, WHO-GMP, USFDA, MHRA, EDQM • Validation & Qualification: Area, Process equipment, process, water system, HVAC, Cleaning, Personnel, Analytical services, Lab instruments • Internal Audits & Customer Audits • cGMP audits • Vendor audits & Vendor qualification • Laboratory set up, up-gradation to FDA, WHO- GMP, USFDA, MHRA, EDQM, GLP & GMP Standards. • Recruitment and Training • Specifications: Raw material, Packing material, In Process materials & Finished products specification • Ayurvedic formulation development & documentation as per FDA requirements • ISO 9001:2000 & PS 9001:2000, Regulatory assignments.

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we provide Regulatory Affairs.We Coordinate with Drugs Control Department and DCGI, State drug controller for Manufacturing License, GMP certificates, free sale certificates, Certificate of Pharmaceutical Product (COPP), wholesale license, DCGI, NOC DCGI, LLIN Registration with Central insecticide boardNational Institute of Malaria Research, NOC from Central Bureau of Narcotics, etc.

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