Business Process Outsourcing in Healthcare Regulation
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Welcome to PCS!

PCS provides technical assistance to onboard R&D organizations to vet research programs and projects in timely and cost-effective manner. PCS creatively utilizes advanced technology and guidance from global regulatory agencies to help the pharmaceutical and biotechnology industries improve information management processes and procedures.

In the pharmaceutical and biotech industry, there is an ever-increasing pressure to streamline core competencies and skills, effectively and efficiently manage information flow, and to reduce development time costs and to bring products to market in a timely manner. As a result, companies are forced to farm out components of the development process, which has the propensity to complicate integration and vetting of chemistry,  manufacturing and controls documentation along the course of development. PCS Network provides resources and expertise to enable companies and organizations achieve excellence in their submissions including, but not limited to the following:

  • Technical and business outsourcing support in the life-sciences, insurance and healthcare
  • Assessment and review of chemistry, manufacturing and controls (CMC) documentation
  • Due diligence review of supportive product development data
  • Technical review and assistance with formulation and preformulation science
  • Stability assessment of product stability and statistical treatment of data
  • Supportive assistance with development of targeted systems, i.e. aerosols, transdermal products, and sterile SC formulations
  • Web-based systems and electronic documentation  

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