Pharma & Biotech

Pharma & Biotech companies operate in a highly competitive and tightly regulated environment. Working with clear, consistent, easy-to-update and audit-ready SOPs, Work Instructions, Batch Records and more are an absolute must for these companies.

GDP is key

Information Mapping® meets documentation challenges by providing Pharma & Biotech companies with:

  • clear, effective documentation that minimizes regulatory agency review time

  • SOPs that reduce manufacturing cycle time
  • quality Manuals that support compliance, and
  • training materials that decrease error rates and improve productivity.

Pfizer, image by Irene Suchocki via Etsy Shop

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.
  • Creating standards and templates for creating NDAs, ANDAs, 510(k)s and other drug and device submissions.

More information

In need of better documentation practices? Contact us to learn more >

Watch our video to see how we help Pharma and Biotech companies.

    Downloads

    Before & After examples

    Case study & testimonials

    Read a case study and testimonials from organizations that use Information Mapping®.

    Emergent

    Information Mapping as a content standard at Emergent

    USFDA Approvals come 75% faster than earlier with no questions asked.

    Dr. Reddy's

    ,

    80% reduction in deviations in manufacturing process.

    ,