and Quality Compliance Services
organizations
and ethics
Nitin Kalra is a dynamic and astute leader with 15 years of experience in Pharma Regulatory and Government Affairs.
Nitin has honed his skills through distinguished roles at Central Government, renowned MNC’s & Domestic organizations i.e. CDSCO (Ministry of Health & Family Welfare), Sanofi, Glenmark, Abbott Etc.
He is proficient leader in Business strategy integration with Regulatory Affairs, Stakeholder Management & Regulatory Intelligence, Policy Advocacy & Due diligence, Successful representation to various government authorities etc
He is driven by competitions & challenges and has a proactive approach to deal with key regulatory agencies including the Ministry of Health & Family Welfare, Ministry of Environment, Forest & Climate Change, Ministry of Agriculture, Ministry of Science & Technology, National Institute of Biological, Department of Biotechnology, Central Drugs Laboratory, Indian pharmacopoeia commission (IPC), DSIR among others.
Nitin is B.Pharma & holding PG Diploma in Regulatory Affairs from Jammia Hamdard University, Delhi.
Area of services
New Drug Approvals
Biosimilars/ Biologicals (rDNA /Vaccines /Blood Products)
Global Clinical Trials
Import & Registration
FDC/LVP Approvals
Subsequent New Drug Approval
Diagnostic Registration
Medical Device Registration
Veterinary
Cosmetics
FSSAI
BA/BE NoC
We are always ready to help you out
We offer regulatory guidance and quality compliance services to manufacturers & Importer across the healthcare industry. Our expertise spans Pharmaceuticals, Medical Devices, Food, Cosmetics, Nutraceuticals, Phytopharmaceuticals, and Herbal products. Partner with us for tailored solutions in quality and regulatory affairs.
Call Us
+91-9958076020
Email Us
Nitin@transparon.com
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