GMPs are the driving governance for all project stages of the clinical phases. The quality system at PMI Bio is regularly maintained, improved, and updated to ensure processes are efficient while maintaining compliance with regulations. We are continually improving our Change Management system, CAPA system, data trending and tracking, product quality and annual reviews, and Quality management reviews to provide quality products and services to our clients.
- Staff receive thorough training in each manufacturing process and the use of GMP procedures.
- Equipment and facilities are qualified for their intended uses.
- Analytical methods are validated.
- Processes are validated for each clinical phase in accordance with current regulatory guidelines.
Our Supply Chain team will work with you on sourcing the materials you need for your specific project. We manage materials from APIs and raw materials to finished drug product. We provide distribution of clinical trial supply to client specified locations and offer temperature controlled shipping. We have developed our processes to mitigate risks to product safety, identity, strength, purity, and quality.
Our team has the knowledge and experience for the handling of temperature sensitive materials over the course of the distribution process. We will work with our clients to support upfront design, packaging recommendations, and shipper qualification. We offer refrigerated storage for temperature sensitive materials and finished drug product.
We have 7,300 ft2 of cGMP-compliant warehousing space and 400 ft2 of refrigerated storage. We are capable of the following storage conditions:
- USP Controlled Room Temperature (CRT): +15 °C to +30 °C
- Refrigerated: +2 °C to +8 °C
- Frozen: -15 °C to -25 °C
Our team will work with you to ensure your needs are met whether it is storage of APIs and raw materials to distributing finished drug product to your clinical trial sites.
We have a team of highly skilled Validation and Process Engineers that work to meet the validation needs of our clients. We can perform cleaning validation, equipment validation, sterilization cycle validation, analytical method validation, and validation of computerized systems.
Our team works with clients to facilitate regulatory strategy and interaction with regulatory bodies. We provide support and guidance on regulatory submissions such as, INDs and IMPDs, and can prepare regulatory documents for clients.