Process Validation
Process Validation Companies (7)
Process Validation News
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News Thermo invests $50 million to enhance biologics capabilities
With the capacity expansion, Thermo Fisher will have the second largest base of single-use bioproduction capacity at a CDMO in the world. -
News Industry’s largest survey on serialization readiness throws up disparity
Global Drug Supply, Safety and Traceability Report reveals disparity in industry’s readiness to comply with track and trace regulations in the US and EU.
Process Validation Products (19)
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Product Biologic drug substance CDMO services
From pre-clinical development to commercial supply, Patheon by Thermo Fisher Scientific is an industry leader in the development and manufacture of mammalian cell culture drug substances. Patheon offers biotech and pharmaceutical companies the ability to pursue opportunities around the globe with a fully i... -
Product Oral Solid Doses
Synerlab is a well known and highly regarded producer of dry forms specializing in small, medium and large production batches runs. We offer a wide range of technologies, including tablets, coated and sugar coated tablets, hard and soft gelatin capsules, in different packaging options (blister, bottle, alu... -
Product Automated NIR Spectroscopy
The SPECTRA NIV is a high speed inspection platform for the non-destructive acquisition and analysis of NIR spectra of lyophilized products. NIR spectroscopy allows the determination of multiple parameters simultaneously such as moisture concentration, defects of the lyophilizate and the identification of ... -
Product GxP Audits and Inspection Readiness
Our auditors have real world experience supporting regulatory inspections and preparing companies for pre-approval inspections.
Our team of specialists includes former regulatory agency inspectors and qualified auditors who are proficient in conducting mock inspections, internal audits... -
Product Commissioning & Qualification
Our qualified consultants strive to exceed your project goals and objectives
Our flexibility and project experiences range from the qualification of an individual piece of equipment to an entire facility.
Our PharmEng professionals have extensive experience in the development, imple... -
Product Analytical Services
Pharmaffiliates is providing all the Analytical Services (i.e. Method Development, Method Validation & Transfer, Stability Studies, Contract Analysis, etc) -
Product Process Development
BioDuro-Sundia’s process development services support drug substance production, providing an efficient path to manufacture API or intermediates. Our extensive services support production of API for GLP toxicology studies, IND-enabling studies, clinical studies, and commercialization efforts. qq... -
Product Development Sciences
Our development laboratories are well equipped for conducting a diverse range of experiments. These encompass formulation development, cycle design and process refinement, as well as evaluating finished product. Ease of scale-up is accomplished by completing process development studies within a pilot scale... -
Product Freeze drying
The value proposition generated through two sites specialized in freeze drying is unique, from manufacturing process optimization to producing freeze dried characterized and documented vials, allowing our clients to diff erentiate on their own markets. We recently invested 7 million euros to increase capac... -
Product Automation Engineering Solutions
We provide solutions and technologies that reduce human intervention and increase efficiency.
Automation is offered in DCS projects independent of the automation vendor. We offer professional services in implementing Automation process control and maintenance in accordance with industry standards ... -
Product Training
Our Subject Matter Experts provide training that fulfill all regulatory requirements
Training is an integral part of GMPs. The operations involved in the manufacture of regulated products are highly technical in nature. Inadequate training of personnel can result in products failing to meet the ... -
Product Engineering
We help bring concept ideas to life
PharmEng engineers are experienced in building scalable and robust pharmaceutical production facilities and processes while employing state of the art techniques to meet and exceed operational and regulatory requirements.
Our experts have succes... -
Product Validation
Our team of experts will prepare necessary protocols incorporating all critical parameters
Process Validation:
PharmEng professionals possess experience in validating pharmaceutical and biopharmaceutical manufacturing processes. Our team of experts will prepare necessary protocols i... -
Product Digital Validation Solution GO!FIVE
Global Verification & Validation SaaS solution for Life Science companies that complies to EMA/FDA. FIVE Validation developed a SaaS platform that is possible to proceed with validation studies 5x faster, compared to a manual (electronic or paper-based) process. -
Product Consulting: Quality Management System
Quality management systems (QMS) are crucial for the success of any business. They provide an accurate way to track and measure quality across all areas of your company. One key benefit of a quality management system is that it establishes clear goals, roles, and responsibilities. It also tracks the pr... -
Product Consulting: ICH Q10
Pharmaceutical companies must be capable of delivering products to the market with the utmost level of quality and safety. At Zamann Pharma Support, we have been aiding large and mid‐sized pharmaceutical companies in solving quality and compliance challenges while ensuring that practicality and qualit... -
Product SAL017 STERIND: Chemical Indicator Labels for Autoclave (1 Box x 500 labels)
SAL017 STERIND: Chemical Indicator Labels for Autoclave (1 Box x 500 labels)Chemical indicator for autoclave -
Product Thermohygrometer – testo 608
Testo offers testo 608 thermohygrometer for measurement of humidity/dewpoint/temperature incl. battery. Testo 608-H2 alarm hygrometer reliably indicates when humidity and temperature limits have been exceeded in garden centres, warehouses, cleanrooms, museums, laboratories etc, to name a few.
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