Whether you need contract manufacturing or an implementation of your company’s platform technologies, Pisgah Labs has a wide range of capabilities:

• Capacities ranging from glassware through 2000 gallon equipment;
• Fully validated reactor trains designed according to a suite concept where each suite is maintained as a controlled environment with dedicated HEPA filtration;
• Three multi-purpose suites to accommodate the variable needs of a dynamic marketplace;
• Multi-ton large scale manufacturing available for extensive or lengthy syntheses;
• Aseptic API manufacturing available at the 50 gallon scale; if needed, the design features of larger equipment suites are available for aseptic validation;
• Production supervision and QA oversight rigorously monitor our operations for compliance to cGMP standards through written SOPs, protocols and batch sheets;
• Production documentation, particularly during a project’s validation stage, is thoroughly integrated with the development process to meet the requirements for successful regulatory submissions (DMFs, ANDAs and / or NDAs);

Our approach has produced a successful FDA compliance history covering continuous compliance audits (cGMP) and Pre-Approval Inspections (PAI).