cGMP Regulatory Issues

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cGMP Regulatory Support 

List Labs staff has over 20 years experience producing cGMP drug substances for clinical trials and commercial drug products. List Labs has filed several Drug Master Files with FDA and Health Canada on behalf of our clients and has provided clients with CMC sections for IND filings.  As required by the State of California, List Labs holds a Drug Manufacturing License enabling us to produce IND and commercial products for our clients. 

There are many regulations and guidances to which we comply. For FDA regulated products, these include the cGMPs (21 CFR 211) and several FDA Guidances for Industry: 

  • Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms; 
  • Early Clinical Trials with Live Biotherapeutic Products;
  • Chemistry, Manufacturing and Control Information, and 
  • Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.
Navigating Toxin Compliance

List Labs complies with federal regulations covering the possession and handling of bacteria and toxins. We have designed a laboratory to provide the appropriate containment to protect both laboratory workers and the environment. Documented procedures and a well developed training program support operations compliant with regulations.

List Labs is registered with the CDC Select Agents and Toxins Program for Tier 1 agents, and the staff is trained and experienced in BSL 3 large scale manufacturing. During more than thirty years of experience in working with toxins and bacteria, we have developed the necessary infrastructure to support manufacturing and shipping according to regulations. We can apply our knowledge to your project and help you develop an approach to compliance. 

Contact us to learn more.

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"When performing detailed electrophysiology studies, it is important to have the highest quality starting material. Having tried alpha-HL monomers from various vendors. we found that the material from List Biological performed the best in terms of activity, repeatability, and quality of data produce."
- Jason Poulos, Chief Executive Officer Librede Inc.