About Us - Overview

Overview
The Azopharma Product Development Group provides both full product development and stand-alone services for the pharmaceutical, biotech and medical device industries. From preclinical to late phase development projects, The Azopharma Group excels at meeting project deadlines while maintaining industry leading quality standards.

Full Development Services
Our goal at The Azopharma Product Development Group is to help you maximize your financial resources by accelerating your timelines. Our proprietary Phase I Express™ process is designed to accelerate your drug development by leveraging our ability to manage the execution of multiple projects along parallel timelines. Throughout the development process, we can provide expert guidance in dealing with regulatory agencies, including IND and NDA filings. Phase I Express™ begins with the synthesis of your NCE followed by its characterization, preformulation development and qualification of the necessary analytical techniques, assuring proper identification, quality and purity. We also provide the preclinical, toxicology and bioanalytical services necessary to support your IND filing.

The Azopharma Group also provides formulation services in a variety of dosage forms and in support of preclinical and clinical studies. Starting with Phase I, we can manufacture your clinical trial material under cGMP as well as conduct the clinical trials through Phase IIb, including analytical support. Concurrently, we can provide CMC analytical services including stability studies necessary for NDA filing.

Specialty and Stand-alone Services
The Azopharma Group also provides a variety of specialty and stand-alone services to support your product development efforts. We specialize in handling cytotoxic and potent compounds and have vigorous controls to insure their safe and proper handling. Other specialty services include respiratory services for MDIs and DPIs and drug delivery technology for customized release profiles and poorly soluble drugs.

Although we provide a continuous spectrum of development services, Azopharma can also provide stand-alone services to support whatever needs our clients may require.