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?

Contact us to learn more about our


    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

    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.

    At Aurobindo, we use the Information Mapping® (IM) Methodology and FS Pro for Word software for drafting SOPs, which are key drivers for the pharmaceutical industry. Because of its well-designed structure, our SOP writers are happy that they spend less time on formatting the documents. Through IM SOPs, the ease of navigating through the document and finding information in the document during execution and audits has improved considerably. Overall, IM has changed our approach towards structured document drafting and simplified our documents.