Services

Drug Development

  • CMC support at all phases of development
  • Global clinical trial planning and management
  • Support for product licensing applications
  • Regulatory management

ProPharma Partners serves client companies in a variety of product development capacities, including:

  • Development of strategic plans for product development
  • Management of medicinal chemistry and CMC activities
  • Design and management of clinical studies
  • Preparation of regulatory applications and reports
  • Assisting clients in meetings with regulatory agencies, and
  • Representing clients in meetings with potential corporate partners and investors.

 

The development plans are always designed with the requirements of the desired therapeutic indications in mind.

ProPharma Partners is able to apply its considerable experience in CMC, regulatory and clinical development to assist companies in defining clinical plans that will be acceptable to regulatory authorities.

In particular, ProPharma Partners has extensive experience in assisting companies define the most efficient and cost effective set of studies that will be necessary for a regulatory filing.

Client Focus

  • Define pharmaceutical development objectives
  • Agree on strategy and plan
  • Assure timely implementation
  • Provide defined deliverables
  • Strive for successful outcome