Darshan Singh

Darshan Singh

Author is a pharmaceutical quality and regulatory professional with more than 23 years in drug manufacturing. He holds an M.Sc. in Organic Chemistry and a Diploma in Pharmacy. He has served as Quality Control Head, Quality Assurance Head and Plant Head, overseeing all manufacturing operations. He is co-founder and regulatory consultant at Laafon Galaxy Pharmaceuticals. He writes on SOPs, manufacturing processes, Schedule M compliance and drug pharmacology, and checks each claim against pharmacopoeial and regulatory sources.

USFDA Approval Roadmap for Indian Formulation Plants

USFDA Approval Roadmap for Indian Formulation Plants

For an Indian formulation plant, “USFDA approval roadmap” essentially means that both your facility and your products meet United States Food and Drug Administration requirements for quality, safety, and compliance with current Good Manufacturing Practice (cGMP) under 21 CFR Parts…

Pharmaceutical Plant Design Consultants in India

Pharma Plant Setup Consultant

Facility Design & Engineering Pharmaceutical Plant Design Consultants in India GMP-driven concept and layout design for formulation, sterile, API, cosmetic and AYUSH facilities — room classification, personnel and material flow, and pressure cascade logic, defined before a single drawing goes…