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.
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
Our clients include:
Abbott | Allergan | Australian Pharmaceutical Industries | 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
See these case studies for more details.
The Medical & Healthcare field is both highly regulated and highly competitive. Organizations are concerned with containing operating costs and growing market share while maintaining quality of service and remaining compliant with the requirements of regulatory bodies.
Information Mapping provides expert assistance to help them
- create clear, effective and compliant SOP’s and work instructions
- design and develop internal training materials that reduce time to proficiency and support performance
- create user guides and reference documentation for their internal systems
- develop e-architectures that enable customer service representatives and salespeople to quickly and easily retrieve the information they need to resolve customers’ issues
American Red Cross | Canadian Forces Health Services | Health Canada | Molina Healthcare | Veterans Health Administration | The Hospital for Sick Children