NSF-DBA Expands Pharmaceutical Services in India through Collaborative Agreement
Partnership brings essential pharmaceutical quality training, auditing, consulting and testing services to India’s fast growing pharmaceutical market
BANGALORE, India — NSF-DBA, an NSF International Health Sciences Company with more than 25 years of experience in the pharmaceutical industry, has signed a collaborative agreement with Semler Research Center Pvt Ltd. (SRC) of Bangalore to expand pharmaceutical training, auditing, consulting and testing services throughout India.
India has one of the fastest growing pharmaceutical markets in the world. Currently ranked 14th, India’s pharma market is expected to grow by $14 billion, becoming the 10th largest pharma market by 20151. NSF-DBA’s partnership with SRC provides global and India-based pharmaceutical companies with local access to essential training, consulting, auditing and testing services. More than 150 companies worldwide ranging from top 10 pharmaceutical companies to small start-ups rely on NSF-DBA’s services to help ensure the safety and quality of their suppliers and pharmaceutical products.
SRC, the Indian subsidiary of a U.S.-based Arnold A Semler Inc., specializes in all aspects of pharmaceutical development, clinical services, bioavailability/bioequivalence testing and GxP2 auditing and consulting. Under the collaborative agreement, NSF-DBA will work with SRC to harmonize consulting and auditing practices and standards, as well as train SRC staff to deliver NSF-DBA training courses. In addition, NSF-DBA services in India now include:
GxP Consultancy Services
Through SRC’s team of GxP expert consultants in India, NSF-DBA can provide auditing, consulting, onsite GMP remediation and validation, and training to international standards for pharmaceuticals, medical devices, and dietary supplements.
NSF-DBA can now provide phase I clinical studies and bioavailability/bioequivalence studies, including the design and management of clinical trials from Phase I to Phase IV for pharmaceutical enterprises.
NSF-DBA can now provide extensive laboratory capabilities in India, including analysis of samples in support of bioavailability/bioequivalence studies.
Formulation, Process and Analytical Development
SRC’s Bangalore facility maintains pilot scale manufacturing equipment, allowing NSF-DBA to develop formulations and processes for a range of dosage forms - from oral solids, through semi-solids, to liquid injectables.
“We asked for recommendations from trusted clients and professionals in the region and one name came up time after time – SRC in Bangalore,” said Bob Pietrowski, NSF-DBA Managing Partner. “This agreement with SRC allows NSF-DBA to better assist companies in Europe and North America who are seeking audits of suppliers and contractors in the region as part of their supply chain assurance program.”
“This collaboration with NSF-DBA brings a host of high quality and competitively priced pharmaceutical services to companies based in India. The consultants of SRC, trained by the reputed Senior Consultants of NSF-DBA, provide a wide range of services, including auditing of API (active pharmaceutical ingredient) facilities, training, consulting, pre-audit services, due diligence audit, and other pharmaceutical-related services that help ensure the safety of pharmaceuticals,” said Gurudatta G.G., Chief Quality Officer, SRC.
Editor’s note: To schedule an interview with an expert from NSF-DBA, contact Greta Houlahan at +1 734-913-5723 or Houlahan@nsf.org.
About NSF-DBA: Since it’s foundation in 1986, NSF-DBA has risen to become a major global training, consultancy and auditing provider to the Pharmaceutical, Medical Devices and Dietary Supplements industries. NSF-DBA has an outstanding international reputation not only for training but also in the fields of quality management and regulatory compliance. NSF-DBA’s services are the first choice of major multinationals and small start-up ventures on every continent.
About NSF International: NSF International is a global independent organization that writes standards, tests and certifies products for the health science, food, water and consumer goods industries to minimize adverse health effects and protect the environment (nsf.org). Founded in 1944, NSF is committed to protecting human health and safety worldwide. NSF is a World Health Organization Collaborating Centre for Food and Water Safety and Indoor Environment.
NSF-DBA is part of the NSF International Health Sciences Division, which offers certification, training, consulting, GMP and GLP testing, R&D and auditing for the pharmaceutical, dietary supplement and medical device industries. The division includes NSF Pharmalytica, a GLP & GMP contract laboratory; NSF Reference Standards; and NSF Dietary Supplements. NSF's Health Science Division operates globally throughout Europe, Middle East, Africa, Asia and the Americas.
1 Kumra, Gautam, Palash Mitra, and Chandrika Pasricha. India Pharma 2015: Unlocking the Potential of the Indian Pharmaceutical Market. Rep. McKinsey & Company. Web. <http://www.mckinsey.com/locations/india/mckinseyonindia/pdf/india_pharma_2015.pdf>.
2 GxP includes Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clincial Practices (GCP), Good Distribution Practices (GDP), Good Pharmacovigilance Practices (GPvP), and Quality Management Systems (ISO).
CONTACT: Greta Houlahan