Regulatory Submissions

Product Development

Ø  Vendor selection and coordination

Ø  Solid dose formulation

Ø  API route selection and synthesis

Ø  Method development

Ø  Establishment of specifications

Ø  Injectable formulation (lyophilization/aseptic and terminal)

Ø  Liquid and semi-solid formulation

Ø  Package development


Clinical and Commercial Supply
Clinical Development
Product Development
Validation Services
cGMP and GCP Audits
Quality Systems