PharmaSys Compliance Solutions
Speed up your Process Development & Validation Program
PharmaSys personnel are experienced in process development, scale up, process optimization and process validation. As a full service compliance firm, PharmaSys can provide customers with strategies to ensure manufacturing processes are robust and the defined critical parameters are based on data driven scientific techniques such as Design of Experiments (DOE), Design for Manufacturing (DFM), and Quality by Design (QbD). PharmaSys personnel understand the Chemistry, Manufacturing and Control (CMC) requirements for regulatory submissions and utilize that knowledge to develop the strategies to produce the required data.
As an extension to our process development service, PharmaSys can provide the expertise to develop your process validation strategy and manage execution of the validation process as required. In addition, PharmaSys can utilize our personnel expertise to help troubleshoot problem areas in your manufacturing process. We can perform and manage Failure Mode Effect Analysis (FEMA) events, risk assessments, root cause analysis, and data mining.
Whether you are scaling up a new manufacturing process, expanding your process into additional facilities or making changes to an existing process, our engineers have the technical skills, compliance knowledge, validation experience and leadership to get your process validated with the least amount of time and expense to you.
Comprehensive Process Knowledge
Extensive Regulatory Experience
Thorough Process Validation Skills
Exceptional Leadership Ability
Areas of Expertise
Sterilization processes (autoclave, e-beam, gama, EtO, dry heat)
Bioreactions & fermentation
Upstream/Downstream Purification (Chromatography, Centrifugation, Ultrafiltration)
Aseptic process simulations (Media Fills, etc.)
Annual product reviews
Bulk API chemical processes
Solid dosage processes
Ointments, creams, liquids