Clinical Trial Material (CTM) Manufacturing

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 Material (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 Material (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. 
 
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.  

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.  
 

Pharmaceutics International, Inc.
10819 Gilroy Road, Hunt Valley, MD 21031
Phone: 410 584-0001 Fax: 410 584-0007
www.pharm-int.com
Mission Statement: To deliver a quality dosage form development service which meets all of our customers’ needs in a timely fashion