Pharmaceutical or Therapeutic Product Testing

Before a new pharmaceutical, OTC, medical device or nutritional product (therapeutic products) enters the market, it must meet an extensive list of requirements and standards. Therapeutic quality testing is imperative for our clients and also the general public.

If you plan on bringing pharmaceutical, OTC, medical device or nutritional products to the marketplace, CPT℠ can provide guidance to help navigate the regulatory and compendial guidelines. From raw materials, assays, stability and finished products to IND, NDA and ANDA submissions, CPT™ can assist with your analytical testing requirements.

CPT℠ can assist personal care companies with testing, such as, low level detection and claims, preservatives and formula stability.

Our Capabilities

  • Raw Material Analysis
    • USP / Ph. Eur. / BP / JP Compendial Testing
    • Wet Chemistry
    • Raw Material Vendor Qualification Programs
  • Pharmaceutical Water Testing
    • Full Monograph Testing
    • Systems Validation and Qualification
  • Method Development & Validation Expertise
  • Low Level Detection and Claims
    • Parabens Testing for “Parabens Free” claims
    • Gluten Testing for “Gluten Free” claims
    • Heavy Metals Testing
    • Elemental Impurities Testing per USP <232>, <233>
    • Extractables and Leachables (e.g. Phthalates)
    • Residual Solvents per USP <467>
  • Preservatives, Antiseptic Products Testing
  • Systems Validation Programs
    • Process Validation
    • Cleaning Validation
  • Stability Shelf-Life Testing
  • Batch Release
  • USP Container Testing
  • Capabilities/Equipment
    • UPLC and UPLC/MS
    • HPLC and HPLC/MS
    • GC and GC/MS
    • ICP/MS
    • IC
    • Dissolution
    • DSC
    • FTIR
    • GFAA
    • UV
    • TLC
    • Titrations
    • Wet Chemistry
  • Controlled Substances (DEA Class I-V license)

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