Whether a project is limited or extensive, logistics, quality assurance, and regulatory compliance need to be addressed — and we’re here to help.
Good manufacturing practice (cGMP) governs all aspects of clinical trial material production. At PMI Bio, our quality assurance team ensures that staff are thoroughly trained in manufacturing and cGMP procedures; equipment and facilities are qualified for their intended uses; and our quality system is continually updated to ensure process excellence and regulatory compliance.
“PMI’s Quality team works closely with each client to make sure every stage of their project is compliant with regulatory requirements.”
BS in Biology
- 25+ years of experience in pharmaceutical and biotechnology production and quality management, including ensuring quality at a new Gardasil® vaccine facility for Merck
- Has supported all dosage forms at all stages from Phase I through commercialization
- Responsible for all aspects of the Quality Management System
- Passions: Reading, sports, and music
The PMI Bio supply chain team will source the APIs, raw materials, and finished drug products you need. Our processes mitigate risks to product safety, identity, strength, purity, and quality.
Cold Chain Solutions, Storage, and Distribution
In pharma manufacturing, particularly biologics, temperature-sensitive materials are the norm. Our team is well-versed in cold-chain solutions for raw material and drug product distribution, including design, packaging recommendations, and shipper qualification.
We will store your temperature-sensitive APIs, raw materials, and finished drug products as needed and distribute your clinical trial supplies wherever you wish, via temperature-controlled shipping.
- 7,300 square feet of cGMP-compliant warehousing space
- 400 square feet of cold storage:
- +15 °C to +30 °C (USP controlled room temperature (CRT))
- +2 °C to +8 °C
- -15 °C to -25 °C
Validation is crucial in pharmaceutical manufacturing to ensure product consistency and safety, as well as regulatory compliance. Our highly skilled validation and process engineers work to meet your needs, including:
- Cleaning validation
- Equipment validation
- Sterilization cycle validation
- Analytical method validation
- Process validation
- Validation of computerized systems
The PMI Bio team will work with you from the start to facilitate your global regulatory strategy — both in the lab and throughout your interactions with regulatory authorities. You’ll feel confident with the documentation we prepare for you and our complete support and guidance for regulatory submissions such as INDs and IMPDs.