Pharma Regulatory Affairs Services

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.