Using good scientific practices, our goal is to move the compound from the preclinical into the clinical development stage as quickly as possible.

 

During the development process, PII and the customer review the formulation data and agree upon the manufacturing schedule for clinical trial supplies based on the customer’s needs and API availability. This enables our customers to make timely decisions from proof of principal studies regarding future clinical development plans.

Clinical Trial Materials (CTM) Manufacturing and Packaging Services

PII can manufacture supplies to support:

Phase I studies

Phase II studies

Phase III studies

Phase IV studies

Production scalability allows for the manufacture of Clinical Trial Materials (CTM) from less than 1 kilogram to 1,200 kilogram batch sizes.

PII provides packaging in bottles and/or blister packs that can be labeled for open and/or blinded clinical studies.

Highly Potent Compounds

With state-of-the-art containment suites, PII is capable of handling specialized compounds including highly potent APIs and steroids.

U.S. Drug Enforcement Administration (DEA) Scheduled Compounds

PII can develop and manufacture CTM supplies for schedule I, II, III and IV DEA scheduled compounds.

Comparator Supplies

Products can be blinded for clinical studies using over-encapsulation and banded to be tamper evident. Matching placebos can be formulated and manufactured for comparative studies.