Pharma & Biotech

SOP templates for Pharma & Biotech


Pharma & Biotech companies operate in a highly competitive and tightly regulated environment. They face enormous pressure from 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.

Our solutions

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

Interesting to read

 

Pharma & Biotech clients

Our clients include:

Abbott | Allergan | Baxter Healthcare | Beckman Coulter | Bristol-Myers Squibb | Eli Lilly and Company | Ethicon Endo-Surgery | Genentech | GlaxoSmithKline | McKesson Corporation | Novartis | Novo Nordisk | Pfizer | Resmed | Roche | Siemens