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ANALYTICAL SCIENCES

 

Are you looking for expertise pertaining to analytical requirements for drug substances and drug products at various drug development stages and associated regulatory filing requirements?   Do you need help deciding whether to use compendial methods or procedures?  Confused about what is necessary for AR&D versus QC in terms of technical staffing,  expertise,  laboratory instrumentation and/or cGMP requirements?   Looking into handling regulated controlled drugs?  Need help with your product stability requirements?  How about qualification and use of Reference Standards versus Reference Markers?   Are you struggling with setting appropriate product specifications or encountering stability failures?   

ANALYTICAL RESEARCH AND DEVELOPMENT (AR&D)

 

  • Regulatory phase-specific analytical method and validation requirements

  • API process development analytical support

    • Key raw materials, In-process controls (IPCs), Isolated Intermediates, Final API

    • Assay, impurities, genotoxic impurities, residual solvents, particle size, polymorphs, moisture, metals, etc.

  • Drug product development analytical support

    • API, Excipeints, Final Drug Product Formulation

    • Assay, impurities, dissolution, residual solvents, hardness, moisture, metals, additives, preservatives

  • Impurity Identification requirements

  • Cleaning development and validation activities

    • method development, surface recovery studies (rinses and swabs)

  • Development and implementation of appropriate tests and specifications

QUALITY CONTROL (QC)

  • Laboratory staffing and operations

  • cGMP Instrumentation Qualification Requirements (IQ/OQ/PQ, calibrations)

  • Method transfer activities and requirements

  • Out of Specification (OOS) and Atypical Investigations

  • API manufacturing process testing activities (Raws, IPCs,  Intermediates., Final API)

  • Drug Product (DP) manufacturing process testing activities (API, Excipients, Blends, Final DP)

  • Testing of manufacturing process validation and cleaning samples

  • Documentation practices

  • Outsourced third party testing

STABILITY STUDIES AND REFERENCE STANDARDS
 

  • Considerations pertaining to in-house or outsourced stability studies

  • Stability storage chambers and cGMP requirements

  • Stability programs in terms of packaging, storage conditions, and testing

  • Key Raw Materials, API, dosage drug products, R&D and cGMP studies

  • Testing parameters, time interval requirements, and duration of study

  • Review stability data for accuracy, integrity and trending

  • Tabulation and organization of stability data for regulatory submission

  • How to assess and remediate stability failures

  • Requirements for Reference Standard and Reference Marker qualifications

  • Management of Reference Standard programs

 

 

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