Pharmaceutical cGMP Services | Current Good Manufacturing Practices

cGMP Services

NCE Development, LLC will carry entire projects, or smaller, focused portions of your drug development efforts.  You can trust that your research dollars will go further, and that the highest level of scientific rigor and data integrity will be maintained as your business goals are met.  With nearly three decades of drug development experience, your projects are in capable, caring hands.

Services include:

  1. cGMP manufacturing of drug substances and drug products
  2. Stability testing of drug substances and drug products
  3. Release testing and issuance of certificate of analysis (COA)
    1. Identity
    2. Purity
    3. Assay
    4. Related substances
    5. Total impurities
    6. Residual Solvents / Organic volatile impurities (OVIs), USP <467>
    7. Moisture by Karl Fischer
    8. Potential genotoxicants
    9. Loss on drying
    10. Bioburden - microbial limits and total endotoxins
    11. Heavy metals
    12. Specialized testing
  4. Batch record writing
  5. Batch record review
  6. Batch disposition assessment
  7. Corrective and Preventive Action Plans (CAPA)
  8. Out-of-specification (OOS) investigations
  9. Deviation assessment and reporting
  10. Vendor assessments / audits
  11. SOP writing
  12. Raw material procurement
  13. Cleaning method development and validation
  14. Analytical method development and validation
  15. cGMP training
  16. Chemistry, Manufacturing, and Controls (CMC) regulatory writing