SL Pharma Labs has extensive experience in working with clients focused on both large and small molecules as well as novel technologies. These clients range from large, multi-national through virtual start-up organizations. Cleanrooms are available in ranges from Class 100 – Class 100,000. SL Pharma Labs has maintained a clean record with the FDA since establishment of the company in 1997.

In addition to research and development support, analytical/microbiology laboratory and clinical manufacturing services, SL Pharma Labs offers documentation support for IND, NDA and ANDA products including technology transfer and regulatory documentation.

Pre-Formulation and Formulation Development

  • pre-formulation
  • formulation development
  • drug/excipient/packaging compatibility
  • process development
  • container/closure system evaluation
  • manufacture of lab-scale and feasibility batches
  • early stage stability studies for active drug substances and product formulations

Analytical Development

  • analytical support for all phases of product development through commercial manufacture
  • raw material testing
  • USP/EP compendia testing
  • forced degradation
  • ICH stability testing & storage of drug substances and finished products
  • methods development and validation ICH
  • technology transfer
  • Commercial release and stability testing
  • Cleaning validation and other special analytical development studies

Microbiological Development

  • sterility test method development, validation and testing
  • microbial examination test method validation and testing
  • bacterial endotoxin test method validation and testing
  • antimicrobial preservative effectiveness testing
  • particulate matter testing
  • container and closure integrity testing
  • antimicrobial evaluation studies
  • special research studies

Clinical Manufacturing

  • Phase I and II parenteral, liquid and topical small scale manufacturing (fill/finish)
  • master batch records
  • in process and full release testing
  • packaging and labeling
  • CMC documentation

Consulting Services

  • training and staff support for new employees
  • functional consulting for quality, analytical, microbiological and regulatory projects
  • 3rd party conflict resolution
  • support of patent and IP litigation