Services - CTM Manufacturing

Early clinical trials require that an NCE be manufactured under cGMP conditions. Through AvivoClin’s affiliation with the Azopharma Product Development Group, our sponsors have an opportunity to accelerate development of their lead compounds through our Phase I Express™ process. AvivoClin can evaluate the sponsor’s protocol and estimate drug supply needs for clinical trials.

AvivoClin can also prepare the required materials for clinical trials to support up to Phase IIb studies. Additionally, AvivoClin can label materials for double-blind studies. For trials in Europe, AvivoClin uses a Qualified Person (QP) to release materials for use in EU clinical trials.

Formulation Capabilities:

• Solid oral dosage forms
• Semi-solid dosage forms
• Topical dosage forms
• Liquid dosage forms
• Inhalation dosage forms
• Cytotoxic dosage forms
• Parenteral dosage forms
• Controlled substances
• Highly potent drugs
• Analytical support
• Technology transfers

Packaging and Comparator Supplies:

AvivoClin provides packaging in bottles, tubes, vials and/or blister packs that can be labeled for open and/or blind clinical studies. Products can be blinded for clinical studies using over-encapsulation and banded as a tamper proof precaution. Matching placebos can be formulated and manufactured for comparator studies.