Pharmaceutical

There are a myriad of challenges facing the pharmaceutical industry -from mergers and acquisition to globalization; increased government scrutiny of regulatory compliance, and pressure to increase quality and safety while reducing the cost of drugs compound these challenges. Nopras Technologies personnel average over 20 years of experience in product life cycle; from design, laboratory analysis, clinical development, through manufacturing and product tracking. Nopras Technologies helps companies searching for ways to reduce cost and increase efficiency without compromising compliance with laws and international government regulations.

Our service portfolio covers US FDA and foreign regulations and guidelines. Our experience spans the drug development life cycle, from clinical development to post-marketing scrutiny. Our consultants possess knowledge and extensive experience with cGMP, GLP, GCP, PDMA, ANVISA, ANMAT, ANVIMA, and TGA, EMEA, HIPAA standards and international guidelines such as ICH. Our knowledge of quality standards such as ISO and CMMI is paramount to our work on quality systems with our clients.

Nopras Technologies services for the Pharmaceutical Industry include:

• Program Design
• Operational Excellence
• Regulatory Preparation and Submission
• Drug Development Support
• Regulatory Compliance and Quality Management
• Clinical Operations Excellence
• Validation Protocol Development and Execution