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
Contact us at
ladjei@pcspharm.com |
