AAIPharma offers management of full drug development programs, providing leadership of cross-functional project teams experienced in developing and implementing pharmaceutical projects. Throughout the development process, the Project management staff provides clear communication to ensure that clients are fully informed and knowledgeable of all program activities and progress.
AAIPharma Project managers have extensive knowledge of the drug development requirements in the pharmaceutical, clinical, and regulatory disciplines. They effectively communicate with the scientists and managers from various operational groups to provide comprehensive drug development plans that comply with established regulatory and quality practices, policies and processes.
Our Project management services include dedicated, cross-functional teams that provide strategic solutions incorporating global regulatory strategies from analytical development, formulation development, clinical trial supplies manufacturing and packaging, Phase I-III clinical studies and regulatory filing. Our services are particularly ideal for the small pharmaceutical or biotech company.
As a contractor of services to the pharmaceutical industry, AAIPharma has well-established capabilities, facilities, systems and practices to provide a full array of integrated development services. Our strict adherence to the most rigorous pharmaceutical quality standards have resulted in an enviable history of successful GMP, GLP, GCP and Pre-Approval Inspections by regulatory authorities worldwide.
