The addition of these consulting and technical services is a response to demands of India’s growing pharmaceutical industry.
Maxine Fritz, Executive VP of Pharma Biotech for NSF International, said: "We have been working with India’s pharmaceutical industry for several years, but our new pharma biotech office in Gurugram makes working with NSF International easier than ever before.
"India is one of the world’s largest producers of generic pharmaceuticals and it is important for NSF International to be here so we can help our clients adapt to changing global regulatory requirements."
NSF International provides pharma biotech consulting, training and technical services to India’s pharmaceutical industry, including the following:
- Consulting — authoritative consulting services respected by major pharma and biopharma companies and regulatory agencies around the world
- Remediation — sound pragmatic advice on how to respond to adverse regulatory inspection findings and build a compliant pharmaceutical quality system to avoid future problems
- Auditing — inspections to check for compliance with GMPs, GLP, GCP, PV and CLIA requirements
- Regulatory guidance — regulatory strategies based on corporate objectives for new therapeutics, existing or new applications and combination products, including assessment of applicability of unique programmes and US FDA approval pathways
- Training and education — comprehensive training and education programmes designed to develop the knowledge and skills needed to meet the challenges of a global and complex pharmaceutical industry.
Earlier this year, NSF International partnered with the Indian Drug Manufacturers’ Association (IDMA) to launch an advanced programme in pharmaceutical quality management (APPQM) in Bangalore.
The five-module education programme is specifically designed for Indian pharmaceutical companies to improve the effectiveness of their quality systems. NSF International will host the first training session on 25–28 September 2017.
For more information on NSF International’s pharma biotech services offered in India or the APPQM programme offered in collaboration with IDMA, please email indiapharma@nsf.org.
