Process Validation (Biopharmaceutical Services)

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, vendor and s...

Global Verification & Validation is a SaaS solution for Life Science companies that complies with EMA/FDA. FIVE Validation developed a SaaS platform that allows AI and traditional validation studies to proceed 6x faster than a manual (electronic or paper-based) process.

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...

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...

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 ...

Pharmaffiliates is providing all the Analytical Services (i.e. Method Development, Method Validation & Transfer, Stability Studies, Contract Analysis, etc)

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...

Nelson Labs Europe offers a comprehensive approach toward Extractables & Leachables testing for the pharmaceutical industry. Our approach combines technical and analytical expertise, polymer knowledge and understanding of regulatory requirements, all combined in a tailored approach for our customers.

Our early phase Process Development services focus on bridging the gap between lab scale and GMP manufacturing, ensuring robust scalability and outstanding productivity. In addition, based on our almost 20 years of experience, our late stage Process Development services design and execute process transfer ...

Quality Chemical Laboratories is known for its capabilities in the development and validation of analytical methods for raw materials, drug substances, and drug products. With a strong focus on quality and precision, QCL employs cutting-edge technologies and a highly skilled team of scientists to offer com...

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...

Our analytical scientists provide cleaning validation analysis from our GMP compliant laboratories. We ensure that fit-for-purpose analytical methods are specific for the substances being assayed and suitable to detect contaminants at the specified ARL for an appropriate level of cleanliness (sensitivity)....

The TRH-554-series is a highly accurate temperature & humidity transmitter using a digital technology sensor which gives fast and reliable output. It comes with a LED digital display and is available in flame proof or weatherproof enclosures.

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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• Silicon/Flexible Tubing Sterilization Validation Biologocal Indicator. • Easy to use and install. • No Destruction of Tube. • Available in 10^6 population for steam sterilization.

Yamasa corporation offers a wide range of biochemicals products which includes cytidine (cytidine). Contact us for more information.

Labanalysis offers a wide range of products which includes validation of processes service. It process validation activities in the field of sterilization filtration and performs analytical tests in order to optimize the choice of materials involved, technical support in validation processes. Contact us fo...

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...

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 ...

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 ...