Pharmaceutical Industry

The pharmaceutical industry continues to face challenges from mergers and acquisitions and globalization of research, development, and manufacturing areas and markets. These challenges are compounded by continuous pressure to increase quality and safety and reduce the cost of drugs. Add to this increased scrutiny by government agencies surrounding compliance to applicable regulations and guidances. Companies are looking for ways to become more efficient and reduce costs while maintaining or increasing their level of regulatory compliance with laws and regulations of governments in multiple countries

How Patni Can Help
Patni has been a quality service provider to pharmaceutical companies for more than two decades. Since the release of FDA guidance related to computer systems used in the drug development lifecycle, we have led the way as a compliance and validation solution provider to the industry. Our service portfolio covers US FDA regulations and guidelines as well as foreign regulations and guidelines that apply to our clients with international operations. Our experience spans the drug development life cycle, from clinical development to post-marketing surveillance. Our consultants possess knowledge and experience with cGMP, GLP, GCP, PDMA, QSR, EMEA, HIPAA and international guidelines such as ICH and GAMP. Our knowledge of quality standards such as ISO and CMMI is key to our work on quality management systems with our major clients.

Patni Services for the Pharmaceutical Industry