Affygility Solutions, LLC

About Affygility Solutions, LLC

Our commitment is to assist biotechnology, pharmaceutical, and medical device companies ensure product safety and regulatory compliance. Since 2002, we have proudly served over 800 clients globally. Our team of experts specializes in preparing OEL/ADE Monographs, Occupational Health Categorization (OHC) Reports, custom monographs and SDS authoring services.

Certifications
  • US
  • 2023
    On CPHI since
  • 1
    Certificates
  • 1 - 24
    Employees
Company types
Consultancy
Other
Pharmaceutical company
Contact info
  • 390 Interlocken Crescent, Suite 350, 80021, Broomfield, Colorado, United States

Products from Affygility Solutions, LLC (3)

  • OEL/ADE/PDE Reports

    Product OEL/ADE/PDE Reports

    Affygility Solutions has an extensive database of over 2,300 monographs.

    Our OEL/ADE/PDE monographs prepared and endorsed by our in-house DABT/ERT certified toxicologists. This guarantees compliance with regulatory authorities such as EMA, PIC/S, ANVISA, and WHO.
  • Safety Data Sheets (SDS)

    Product Safety Data Sheets (SDS)

    Safety data sheets are used to determine the potential hazard of the materials being handled.

    2 Weeks Turnaround Time
  • Occupational Health Categorisation (OHC) Report

    Product Occupational Health Categorisation (OHC) Report

    OHC reports are customised safety banding reports for compounds with limited data available. These compounds are usually early stage compounds with little or no human data available.

    An OHC report will contain an occupational exposure band (OEB) and an estimated ADE value. The report&...