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 documentation that supports compliance and boosts your QMS, 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

    My training expectations were totally fulfilled. You made the training sessions very interesting and entertaining. You conveyed the training material very clearly and easy to understand.

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

    Dr. Reddy's

    80% reduction in deviations in manufacturing process.

    Training is informative & enhances knowledge in designing SOPs.