PSC Biotech®

Frequently Asked Questions

Who is PSC Biotech®?

PSC Biotech® is one of the world’s largest specialty life sciences consultancy firms, supporting over 1000 clients in more than 35 countries. For over 25 years, PSC® has provided life science companies with unmatched support through professional service consulting, life science equipment rentals and sales, cloud-based software solutions, and pharmaceutical contract manufacturing.

What does PSC Biotech® do?

PSC Biotech acts as a seamless extension of your business to boost your capacity and assist you in meeting the needs of your customers. PSC offers services in Commissioning, Qualification, and Validation, Computer System Validation and Assurance, Regulatory Affairs, Quality Assurance, Audits, and more providing high-quality and reliable consulting services at a cost-effective price.  PSC Biotech is the preferred partner of BIO for professional services for all quality, systems, and regulatory needs.

What industries does PSC Biotech® work with?

PSC Biotech serves all highly regulated industries. Biotech, pharmaceutical, medical device, chemical, cosmetics, food and beverage, and more. With over 26 years of experience supporting clients around the world, we are experts in helping our life science clients improve the quality of their products and services to meet regulatory requirements and deliver top-quality solutions to customers. Learn more about PSC Biotech’s projects across the globe. 

Biotech

Our specialty is collaborating with life science companies in biotechnology to bring world class innovations to marketing.  

Pharmaceutical

We support pharmaceutical companies in the discovery, development, and production of pharmaceutical drugs.

Medical Device

Our experience in medical technology helps empower MedTech companies to help patients live to live longer, healthier lives.

 

Highly-Regulated Industries

For companies who must comply with good manufacturing practices (GMP) and quality requirements, PSC Biotech is here to provide support.

PSC Biotech® Partners and Memberships

BIOTECanada

Equipment Partners

Equipment Experience

Life Science equipment

Laboratory Equipment

Ensure your lab equipment is designed, built, installed, and functioning as intended through commissioning, qualification, and validation. PSC Biotech®’s commissioning engineers are here to verify compliance with 21 CFR Part 211 regulations and current good manufacturing practices (cGMPs). Our team of experts is experienced in essential laboratory equipment for labs ranging from research, clinical, surgical preparation, and more from leading manufacturers including Thermo Fisher Scientific, Millipore Sigma, Yamato Scientific, Danaher, BD, and more.

Analytical Equipment

PSC Biotech® has the experts you need for validating life science, clinical, and analytical instrumentation from diagnostic to laboratory equipment. Our team of commissioning engineers can validate any instrumentation made to qualitatively and quantitatively analyze samples across fields such as Life Science Research, Pharmaceutical Analysis, Clinical Analysis, Food & Beverage Analysis, and more. We have experience with cross-discipline manufacturers including: Bio-Rad, Fisher Scientific, Shimadzu, Qiagen, and more.

Life Science Equipment

Keep your laboratory equipment and instruments up to date with current good manufacturing practices (cGMPs) while maximizing productivity, developing better quality products and getting to market faster. Our commissioning, qualification, and validation engineers can show you how. We’ve got experience working on lab equipment from manufacturers like Agilent BioTek, Molecular Devices, BMG LABTECH, and Labconco Corporation

Manufacturing Equipment

PSC Biotech is a commissioning, qualification, and validation industry leader for cleanroom environmental monitoring, thermal validation, and mapping in the pharmaceutical, biotechnology, medical device, and life sciences. We are proud to partner with CLiMET and Lives International as distributors of validation equipment. We are experts in quality and validation procedures in compliance with regulatory requirements such as ISO 9001, ISO 17025, ISO 14001, and 21 CFR Part 211.

 

Particle Counters

CI-3100 TRIDENT Series

CI-3100 OPT Series

CI-3100 Trident RS Series

CI-x70 Series NextGen Portable Air Particle Counter For Cleanrooms

CI-x5x Series Portable Air Particle Counter For Cleanrooms

Microbial Air Samplers

CI-97 Cleanroom Microbial Air Sampler

CI-99 Microbial Air Sampler

CI-95A Microbial Air Sampler

CI-90A Microbial Air Sampler

Lyophilizers

SP Hull Production Freeze Dryer – SP Scientific

Lyophilizers (Virtis) – PhxEquip-Stokes

Lyophilizers (Optima) – Optima

More Equipment

High Speed Rotary Tablet Press

Incubators and Stability Chambers – Binder, Labline, Darwin, Sartorious Stedim Cryopilot

Freezers and Refrigerators (-80 to 5 degree )

Blood Gas Analyzer – Radiometer

Cell Counter – Cedex

Laser Particle Size Distribution Analyzers Horiba Instruments

Chromatography Columns and Controllers Pall

 

Regulatory Agency Experience

PSC Biotech has experience meeting regulatory standards around the world. PSC Biotech operates in 52 countries globally and has served thousands of clients to date. Employing an international team of skilled professionals and experts that span strategically located offices across North America, Europe, Asia, and the Middle East, we are proud to serve the global life science community. 

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