OUR PROJECTS
Our Service Related Projects
PAST PROJECTS
PAST PROJECTS
Project Summary, QA
Nov 5, 2021
Regulatory Agency Inspection Preparation & Quality Oversight
Our client, a research foundation in Saskatchewan, brought PSC Biotech on for Quality Assurance services. The client was seeking GLP lab accreditation to aid in their therapeutic development programs. PSC Biotech was able to oversee, arrange, conduct, and report on audits of cGMP facilities, nonclinical systems.
CQV, Project Summary
Aug 12, 2021
Validation & Qualification | Aquatherm SWS Sterilizer (Syntegon)
The client engaged PSC™ to initiate the validation and qualification of a AQUATHERM SWS sterilizer (Syntegon) with a chamber of approximately 2500 ft3. Laboratory and Pharmaceutical Manufacturing equipment validations play a vital role to ensure the quality and effectiveness of the equipment being used for the development of manufactured products.
CSV, Project Summary
Aug 12, 2021
QA CSV | System Implementation & Upgrading
PSC Biotech® is helping our client, a global leader in testing and laboratory services located at St. Louis, with a Watson 7.6.1 system implementation and upgrade, including new servers, disaster recovery, computer system validation, and business process remediation.
Project Summary, Regulatory Affairs
Jul 23, 2021
Regulatory Affairs | Vaccine Registration
This project is ongoing, PSC Biotech® is helping our client located in St. Louis with registration of their animal product (vaccine) in 3 countries, UK, Australia and New Zealand.
Project Summary, Quality Assurance
Jul 14, 2021
Quality Assurance | New Product Development Projects
PSC did multiple projects with this client for their new product development. This included:
CSV, Project Summary
Mar 23, 2021
Calibration Software | Csv | Risk Assessment, Qualification, And Validation
PSC Biotech® performed a Risk Assessment of critical calibration software functionalities and developed a Validation Plan. Our consultant developed configuration specifications, performance qualification protocols, and test scripts for specification of testing of critical calibration software activities.
CQV, Project Summary
Jan 28, 2021
Commissioning | Utilities And Facility
PSC® performed commissioning of utilities, EMS, Electrical and HVAC for this clients facility. The team worked on the environmental monitoring system (EMS): Monitoring for each individual room, at the formulation standpoint. Each room was required to meet a certain criterion for how much pressure was in there.
Auditing, Project Summary
Jan 5, 2021
Regulatory Affairs, Technical Writing | Ind Modification For Phase I Clinical Trial
PSC® supported a small, start-up biopharmaceutical company with their Investigational New Drug (IND) application. With commentary from the FDA and a short time-line, PSC provided updates and modifications to the IND Phase I Clinical Trial Submission to ensure FDA approval.
Auditing, Project Summary
Dec 1, 2020
Nutritional Supplement Manufacturing Facilities
PSC® Provided Supplier Quality Audit services for food and nutritional supplement manufacturing facilities auditing to 21 CFR 110, 21 CFR 111 and customer quality standards.
Auditing, Project Summary
Dec 1, 2020
cGMP Compliance And Gap Analysis
PSC® performed cGMP Program Compliance and Gap Analysis and trained their staff on current good manufacturing practices. The audit also covered US FDA and European Current Good Manufacturing Practices.
Auditing, Project Summary
Dec 1, 2020
Audit Inspection Of cGMP Facility
PSC® performed mock FDA prior approval audit. Performed inspection of cGMP Manufacturing facility and the associated cGMP Quality Systems. PSC® developed audit response plans, corrective action and regulatory compliance plan, and trained staff. PSC®, developed cGMP training content for facilities.
Engineering, Project Summary
Oct 21, 2020
Engineering | Facilities, Utilities & Process Equipment
PSC® has been providing engineering and validation services at the San Dimas facility since 2014. When the La Verne facility startup projects began, PSC® has been providing validation support to keep the facility operational. PSC® covers all aspects of facilities, utilities and process equipment qualification and validation across the entire facility.
CSV, Project Summary
Oct 21, 2020
CSV | Remediation Transition Validation & Compliance Project Management Project
About this Project OBJECTIVE Validation and compliance project for the transition of computerized systems from the previous system SERVICES This…
Project Summary, Regulatory Affairs
Oct 21, 2020
Regulatory Affairs | Strategy Support Projects
PSC® continues to support the Global Regulatory Affairs division for a large biopharmaceutical company, focused on plasma-derived therapies for rare and complex diseases. This company’s headquarters is in Cambridge, MA, but we support locations in the Greater Atlanta region and Greater Los Angeles region.
Project Summary, Technical Writing
Oct 21, 2020
Extensive Technical Writing & Validation Execution
PSC® performed technical writing support for 3 months utilizing a Senior Technical Writer. The project started on 6/10/2020 and concluded on 9/10/2020 or agreed upon timeframe. PSC® provided project schedule oversight through the entire project.
HOW CAN WE HELP YOU
HOW CAN WE HELP YOU
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