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 FDA 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 achieve excellence in their
submissions including, but not limited to the following:
- 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 development data
- 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 e-mail communications
Contact us at
ladjei@pcspharm.com |
