Pharma & Biotech

Pharma & Biotech companies operate in a highly competitive and tightly regulated environment. Using the Information Mapping Methodology helps to create clear, consistent, easy-to-update and audit-ready Policies, Quality Manuals, SOPs, Work Instructions, Batch Records, and more.

Your partner for Good Documentation Practice

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

  • clear, effective documentation that minimizes FDA and EMA review time

  • SOPs that reduce deviations and manufacturing cycle time
  • Quality documentation that supports compliance and boosts your QMS, and
  • Training Materials that decrease error rates and shorten employee training time.

Pfizer, image by Irene Suchocki via Etsy Shop

Implementing our Methodology

Pharma and Biotech companies require documentation that meets the highest standards for quality, consistency and usability. With our proven Methodology, they can harmonize and standardize their document creation processes.

Our Information Mapping Methodology helps you to

  • Design documentation that supports compliance and improves productivity.
  • Define information requirements for SOPs, WIs, NDAs, 510(k)s, quality and batch-related processes.
  • Develop templates for creating NDAs, ANDAs, 510(k)s and other drug and device submissions.

Need help with your documentation project?

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    Before & After examples

    Case study & testimonials

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


    Information Mapping as a content standard at Emergent

    80% reduction in deviations in manufacturing process. 1 month without a deviation at our site for the first time in company history.

    81% decrease in time to find key info.

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

    Dr. Reddy's

    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.

    Training is informative & enhances knowledge in designing SOPs.