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PSC Biotech - Professional Services
- 2. PSC BIOTECH™ Professional Service Division For over two decades, PSC Biotech™ has provided life science companies unmatched support through specialized professional services consulting. Our mission is to act as a seamless extension of life science companies in order to produce the highest quality products possible. To date, PSC Biotech™ proudly serves 1000 clients in more than 31 countries worldwide. biotech.com | info@biotech.com | 700 Corporate Center Drive Pomona, California 91768
- 3. For over two decades we have organically grown our consultancy to a worldwide business with operations in North America, Latin America, Europe, Asia, and the Middle East. This global footprint helps us service our large, multinational clients in ways that smaller, regional competitors cannot. This also affords us a global perspective on where the life sciences market is going and how to most effectively position our company to meet both current and future trends. Why PSC Biotech™? biotech.com | info@biotech.com | 700 Corporate Center Drive Pomona, California 91768
- 4. We’re proud to work with some of the top life science companies around the world. From medical device to naturopathic, we have the expertise to fit your needs. We’re also proud to have worked with companies from their infancy and through their growth, supporting them when and where they need us. Our Client Base biotech.com | info@biotech.com | 700 Corporate Center Drive Pomona, California 91768
- 5. biotech.com | info@biotech.com | 700 Corporate Center Drive Pomona, California 91768 Professional Service Overview Quality Assurance & Compliance Regulatory Affairs Compliance Management AuditsTechnical WritingCommissioning, Qualification, Validation • Specialized Support • QA Review (GLP, GMP, GCP) • 483/Warning Letter remediation • Risk Assessments • EM Program Analysis/Creation • Microbiology Laboratory Consulting • Post-Approval Reports • BLA Submissions • Drug Master Files NDA/ANDA Submissions • Regulatory Agency Interaction • Consulting • 21 CFR Part 11 Compliance • Audit Services • Gap Assessment • Mock Inspection • Pre-Approval Inspection Readiness Reviews • Large complex projects where clients outsource facility commissioning • New production suite commissioning • Decommissioning • Method transfers and/or validation • FDA Responses • SOPs/Document/Forms • Report Writing • Technical Document Writing Expertise • Supplier • Laboratory • Facility • PAI preparation • cGxP • Gap Analysis
- 6. biotech.com | info@biotech.com | 700 Corporate Center Drive Pomona, California 91768 Professional Service Overview Engineering Services Business Analysis/Support Metrology and CalibrationTechnical WritingInformation Technology • Staff Augmentation • Conceptual • Process Design and P&ID • Facility Optimization • Equipment Selection • Providing high level business analysis within areas of expertise. • Acquisition integration and process mapping • IT Analysis • Configuration • Validation • Project Management • System Integrations • Expert IT Oversight • Engineering • C&Q and Validation Projects • Equipment Rentals • Equipment Sales • Calibration • Thermal Mapping Validation Services • Computerized System & Software Validation • Cleaning Validation Equipment & Facility Qualification • Process Validation • Shipping & Packaging Validation
Editor's Notes
- Welcome everyone! I hope you have enjoyed your time in the city of brotherly love and at Bio 2019! I’m Crystal Booth. I’m a Regional Manager with PSC Biotech Corporation. Today, I’ll be discussing our company and our capabilities on becoming your life science solutions partner.
- PSC is globally recognized. We have highly skilled experts based around the world in strategic locations to provide the best service possible to our clients. Our current global network helps us to meet current and future trends in the industry so we are always ahead of the game. We can easily help global clients stay compliant with regulations in different parts of the world.
- We have clients from all over the world; many of whom you may recognize. No project is too big or too small. At PSC, we are there when our clients need us. We can help you meet your goals on time and on budget.