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.
Information Mapping’s solutions meet these challenges by providing them with
- clear, effective documentation that minimizes regulatory agency review time
- SOPs that reduce manufacturing cycle time
- batch records that support compliance, and
- training materials that decrease error rates and improve productivity.
Discover some examples of how Information Mapping® can improve your documentation:
- SOP for the operation of tanks in Media Preparation
- GPRD Procedure Document
- Quality Audit Process
- SOP - Testing Drain Water for Microbes (Before & After example)
- Procedure on notification of spills & releases (Before & After example)
- Procedure on opening ampules and extracting medication (Before & After example)
- FDA Non-Compliance Policy (Before & After example)
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
Our clients include: Abbvie | Abbott | Allergan | Baxter Healthcare | Boehringer-Ingelheim | Bristol-Myers Squibb | Celgene | Dr. Reddy's | Eli Lilly and Company | Lupin Pharma | Emergent | Genentech | Gilead | GlaxoSmithKline | McKesson Corporation | Novartis | Pfizer | Resmed | Roche | Sanofi | Siemens | Steris | ThermoFisher