Pharma & Biotech
Pharma & Biotech companies operate in a highly competitive and tightly regulated environment. They face enormous pressure from two conflicting areas:
- shortening time to market to ensure return on substantial R&D investments, and
- complying with the demands of regulatory agencies to meet quality and safety requirements before a product is released
The need to reduce risk while accelerating time to market has become a compelling priority. The industry is seeking new ways to increase efficiency while operating safely and compliantly.
Information Mapping’s solutions meet these challenges by providing them with
- clear, effective documentation that minimizes regulatory agency review time
- SOP’s that reduce manufacturing cycle time
- batch records that support compliance, and
- training materials that decrease error rates and improve productivity.
A new approach
Pharma and Biotech companies require documentation that meets the highest standards for quality, consistency and usability. They need to take a new approach to structuring content.
Information Mapping meets those challenges by
- designing documentation that supports compliance and improves productivity
- defining information requirements for SOPs, NDAs, 510(k)s, quality and batch-related processes, and
- creating standards and templates for creating NDAs, ANDAs, 510(k)s and other drug and device submissions