Expertise

25 years of experience in international and domestic pharmaceutical companies

Strategic direction & guidance on quality system & GMP compliance to succeed in regulatory and Global audits

Execute a strong documentation - Specifications, Standard Testing Procedures, Artworks, Protocols/ reports of Process Validation, Cleaning Validation, Instrument/Equipment Qualification and Stability Study Protocols

Establish and readiness for regulatory inspection from Global Agencies (FDA, MHRA, TGAA, WHO etc.) for commercial formulation plant, and Global API projects in India.