PSC Biotech
PSC Biotech is a leading life science consulting firm that specializes in providing comprehensive solutions to highly regulated industries. With over 25 years of experience, PSC Biotech focuses on ensuring compliance, enhancing operational efficiency, and delivering high-quality consulting services tailored to the unique needs of clients in the pharmaceutical, biotechnology, and medical device sectors. The company operates in 52 countries globally and has served thousands of clients, employing a global team of skilled professionals and experts. PSC Biotech is committed to elevating quality management systems and ensuring data integrity through innovative solutions and partnerships.
PSC Biotech
26 Boon Lay Way, Trade Hub 21 #01-92, Singapore 609970
What We Do
Comprehensive auditing services for life science companies, ensuring compliance with global regulations and standards.
Expert consulting services to ensure that computerized systems meet regulatory compliance and operational efficiency.
A science and risk-based approach to validating computerized systems, focusing on functionality, patient safety, and product quality.
Quality assurance services including QA review, risk assessments, and compliance with GLP, GMP, and GCP standards.
Support for ANDA/NDA submissions and regulatory compliance across various agencies including FDA, EMA, and others.
Expert oversight of IT, Engineering, C&Q, and Validation projects to ensure successful outcomes.
Providing engineering solutions focused on quality, validation, and documentation to ensure compliance with regulations such as 21 CFR Part 211/210/820 and ISO 13485.
Custom solutions for automatically managing material inventory, product orders, and work protocols to enhance operational efficiency.
Calibration and validation services to ensure compliance with GLP, GCP, or GMP standards, including on-site and laboratory calibration.
Development and validation of analytical procedures based on ICH Q14 guidelines, ensuring compliance and continuous improvement in the pharmaceutical industry.
PSC Biotech® works to ensure life sciences companies’ processes are functional and fully compliant with FDA and EMA guidelines. Our CSA consultants systematically follow the ISPE GAMP® 5 model and adhere to current GxP FDA guidance, improving product and patient safety by identifying gaps and risks in the validation process.
PSC Biotech® provides end-to-end solutions for commissioning, qualification, and validation, supporting life science companies in all aspects of the CQV lifecycle.
PSC Biotech® technical writers deliver expertise and services, ensuring regulatory compliance through precise documentation in life science manufacturing.
Key People
Heather Kelly
President, PSC Europe
News & Updates
We will attend the BIO 2024 Come visit us at Booth 5114 & 3027 from June 3rd to June 6th and meet PSC Biotech and PSC Software experts. Schedule a meeting with our Experts to meet at the event.
National Biotechnology Conference
We will attend the National Biotechnology Conference. Come visit us at Booth 604 from May 13th to 16th of May and meet PSC Biotech and PSC Software experts. Schedule a meeting with our Experts to meet at the event.
We will attend the ASQ World Conference on Quality & Improvement. Come visit us at Booth 407 from May 12th to 15th of May and meet PSC Biotech and PSC Software experts. Schedule a meeting with our Experts to meet at the event.
This article discusses common challenges in data integrity, including deletion of audit trails and accuracy of results, emphasizing the importance of maintaining transparency and traceability in data handling.
This whitepaper delves into the key components, benefits, and implementation strategies of ISO 9000:2015 and ISO 9001:2015, offering valuable insights for businesses aiming to achieve and maintain high standards of quality management.
This article outlines the structured framework provided by ICH Q14 for analytical procedure development, emphasizing method validation, lifecycle management, and regulatory compliance.