Parsolex has built a state-of-the-art facility that houses analytical and manufacturing technologies and a team of pharmaceutical experts who have a demonstrated record of successful formulation design, process development, technology transfer, scale-up, regulatory compliance, manufacture and packaging for a broad range of oral solid dosage forms, including but not limited to tablets, film-coated tablets, and hard gelatin capsules filled with powder, granule and coated-beads.

Parsolex has devised successful strategies for development of clinical trial materials, including active comparator and matching placebo products, while maintaining regulatory requirements. To meet the diverse needs of our clients, we have also produced other non-solid products such as semi-solids, syrups, and suspensions.

Parsolex can provide primary and secondary packaging of dosage forms using internal resources or working through vendor partners for special packaging requirements or commercial products that require serialization. Parsolex can also provide guidance with respect to regulatory guidelines, practices, and requirements associated with the manufacture of pharmaceutical drug products.

Our CGMP Manufacturing Solutions are capable of executing a variety of processes that are supported by a range of technologies for operational efficiency, while complying fully with CGMP regulations enforced by the Food and Drug Administration (“FDA”):

• Blending : Intermediate Bulk Containers (“IBC”) for closed transfers and improved batch integrity
• Granulation : Low shear, high shear, and fluid bed (spray) available depending on the physicochemical properties and desired performance attributes of the finished product
• Drying : Tray (convection) or fluid bed available depending on the desired heat and mass transfer rates required during drying
• Milling : Conical sieve wet and dry product mills to achieve the desired particle size distribution
• Tablet Compression : Single station for prototype and small-scale production. Rotary tablet presses for scale-up and full-scale production.
• Coating : Drum coating for cosmetic and functional film coating, including controlled release. Precise spray coatings on particles and beads.
• Encapsulation : Dosating nozzle type equipped with capsule weight checking for 100% verification. Over-encapsulation for blinding of comparators.

Let us know how we can help with your CGMP Manufacturing needs today.