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 reviews the formulation data and along with the client agrees 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 manufactures a wide range of dosage forms for CTM supplies to support Phase I - IV studies including:

-Solid

-Liquid

-Semi-solid

-Sterile (IV, Syringe, and Lyophilized)

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.

Potent Compounds

With state-of-the-art containment suites, Pii is capable of handling specialized compounds including 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.