SL Pharma Labs
Contract development and laboratory organization established in 1997 providing formulation and analytical R&D, microbiological testing, clinical-stage manufacturing (sterile parenteral and topical), stability testing, technical transfer and regulatory documentation support (ANDA/NDA/IND). Operates a cGMP/GLP-compliant, FDA-registered facility with controlled-environment clean rooms and capabilities for controlled substances and cytotoxic compounds.
Industries
Nr. of Employees
small (1-50)
SL Pharma Labs
Products
Contract CMC Services
Customized high quality contract CMC services including formulation, analytical, microbiological development, and clinical manufacturing.
Parenteral Product Development & Clinical Manufacturing
Parenteral product development and cGMP clinical manufacturing for sterile drug products.
Pre-Formulation and Formulation Development
Formulation development services for small and large molecules to support clinical development and commercialization.
Analytical laboratories
Analytical testing services housed in the SL Pharma Labs facility.
Stability chambers
Stability testing services utilizing on-site stability chambers.
Clean rooms for sterility testing and clinical manufacturing
Class 100 to Class 100,000 clean rooms for sterility testing and clinical trial material manufacturing.
Contract CMC Services
Customized high quality contract CMC services including formulation, analytical, microbiological development, and clinical manufacturing.
Parenteral Product Development & Clinical Manufacturing
Parenteral product development and cGMP clinical manufacturing for sterile drug products.
Pre-Formulation and Formulation Development
Formulation development services for small and large molecules to support clinical development and commercialization.
Analytical laboratories
Analytical testing services housed in the SL Pharma Labs facility.
Stability chambers
Stability testing services utilizing on-site stability chambers.
Clean rooms for sterility testing and clinical manufacturing
Class 100 to Class 100,000 clean rooms for sterility testing and clinical trial material manufacturing.
Services
Pre-formulation and formulation development for topical and parenteral drug products, including modern formulation approaches.
Analytical method development, validation and quality control release testing for drug products and dosage forms.
Microbiological method development, sterility testing and antimicrobial effectiveness testing in dedicated microbiology laboratories.
Clinical-scale manufacturing of sterile parenteral and topical products using clean-room suites and cGMP processes.
Preparation of regulatory documentation and technical reports to support IND, ANDA and NDA submissions.
Transfer of development processes and documentation to support commercial production and manufacturing scale-up.
Pre-formulation and formulation development for topical and parenteral drug products, including modern formulation approaches.
Analytical method development, validation and quality control release testing for drug products and dosage forms.
Microbiological method development, sterility testing and antimicrobial effectiveness testing in dedicated microbiology laboratories.
Clinical-scale manufacturing of sterile parenteral and topical products using clean-room suites and cGMP processes.
Preparation of regulatory documentation and technical reports to support IND, ANDA and NDA submissions.
Transfer of development processes and documentation to support commercial production and manufacturing scale-up.
Expertise Areas
- Formulation development for topical and parenteral dosage forms
- Analytical development and stability testing
- Microbiological testing and sterility assessment
- Clinical-stage sterile manufacturing
Key Technologies
- Aseptic processing and clean-room manufacturing
- Stability chambers and ICH stability studies
- Lyophilization (freeze-drying) for injectables
- Liposomal, nanoparticle and microemulsion formulations
News & Updates
Article providing guidance on verifying medicine authenticity, safe online purchasing practices and steps to check drug provenance; published on the company website.
Summary of topics covered by the Research in Social and Administrative Pharmacy resource, including pharmacoepidemiology, health literacy and pharmacy practice research; published on the company website.
Article providing guidance on verifying medicine authenticity, safe online purchasing practices and steps to check drug provenance; published on the company website.
Summary of topics covered by the Research in Social and Administrative Pharmacy resource, including pharmacoepidemiology, health literacy and pharmacy practice research; published on the company website.