Offers customized product development and clinical manufacture contract services to pharmaceutical and biotechnology companies

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REGULATORY/ COMPLIANCE

  • SL Pharma Labs, Inc. provides customized consultation and offers substantial expertise in preparing technical (CMC) documentation to support registration (IND, NDA, ANDA) and assist the clients in resolving complex technical/regulatory issues with the FDA
     
  • SL Pharma Labs, Inc. fully complies with cGMP and GLP regulations. It has an excellent track record with the FDA for GMP compliance and pre-approval inspections (no 483!).
     
  • SL Pharma Labs, Inc. provides customized consultation and training for GMP compliance and pre-approval inspections