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Strategic Planning

 

We collaborate with researchers and other members of the product team to design an integrated development plan based on the science underlying the investigational product.

Guidance in Clinical and Regulatory Affairs

 

We advise on regulatory strategy and implementation of regulations and policies for conducting clinical trials. We also advise on Class I exempt medical devices and 510(k) submissions

Project Management

 

We provide oversight for overall program projects and activities, including adherence to timelines and budgets.

Document and Communications Support

 

We prepare corporate presentations, regulatory submissions, clinical documents and training programs.

Policy Development

 

We develop policies that are compliant with Good Clinical Practices and other regulatory standards for conducting human research.