Product Development Services- CTM Manufacturing and Packaging
Early clinical trials require that an NCE be manufactured under cGMP conditions. Azopharma’s cGMP facilities, experienced team and unique approach to CTM manufacturinggive our sponsors an opportunity to accelerate development of their lead compounds through our Phase I ExpressTM process. Azopharma can evaluate the sponsor’s protocol and estimate drug supply needs for clinical trials.
Azopharma can also prepare the required materials for clinical trials to support up to Phase IIb studies. Additionally, Azopharma can label materials for double-blind studies. For trials in Europe, Azopharma 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
Azopharma 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.