Clinical Supply Manufacturing
Clinical trial manufacturing is one of the specialized custom services provided by IRISYS.
IRISYS has the capabilities to support our clients’ clinical manufacturing needs. Our clinical trial manufacturing department has demonstrated expertise and compliance with Good Manufacturing Practices (GMP) regulations for the clinical manufacturing of pharmaceutical formulations for clinical studies and specialty pharmaceutical products. We understand the chemistry, manufacturing, and control (CMC) guidelines that underscore successful CMC clinical manufacturing.
IRISYS has the experience and capacity to produce a wide range of dosage forms in our state-of- the-art clinical manufacturing facility in San Diego.
We provide packaging and labeling for:
- Sterile fill syringes
- Over encapsulation
- Blister packaging
- Bulk packaging
- Bulk labeling
- Powder in bottle
Our clinical manufacturing organization provides pharmaceutical products in dosage forms needed by our clients.
- Capsules, hard gelatin or HPMC (hydroxypropyl methyl cellulose), liquid-filled
- Capsules, hard gelatin or HPMC, powder-filled
- Capsules, controlled or sustained release
- Tablets, immediate release
- Tablets, controlled or sustained release
- Tablets, enteric-coated
- Topical gels, creams, ointments
- Oral liquids
- Injectables, including lyophilization