Process Validation (Biopharmaceutical Products)

From early development, including mammalian cell line development, cell culture development, and process development, through to pre-clinical production and commercial supply, Patheon by Thermo Fisher Scientific provides CDMO services for protein-based biologic therapeutics. Patheon offers biotech and ...

Blow-Fill-Seal is the most economical way to get your liquids or semi-solids into the perfect shape. But investing in your own equipment doesn't always pay off. For these cases, there is our CDMO service. This means that you have a complete GMP infrastructure, bottelpack technology in various configuration...

Fujifilm Wako provides monocyte activation test (MAT) reagents for pyrogen testing as an alternative of Rabbit Pyrogen Test (RPT). Our LumiMAT™ Kit is used to detect the presence of pyrogenic substances in pharmaceuticals and medical devices without the need for animal testing.
By using these sust...

ValGenesis iVal™ is the leading validation lifecycle management system, delivering AI-assisted digital validation to accelerate speed to market, enhance compliance, and optimize budgets. By combining digitization with AI-driven automation, iVal streamlines qualification and validation, minimizes manua...

As part of its commitment to full service support, PLD Pharma Services is pleased to offer our customers support with ANDA and NDA applications, including bio equivalency studies, collecting background data, supervising technology tranfers and reviewing applications to make sure that companies comply ...

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.

Scale-down process characterization studies performed using a qualified scale-down model are a critical part of licensure applications for biologics. 

KBI has significant expertise in the design and execution of these studies to enable customers to define their process control strategy to take ...

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...

The TRH-100 is battery operated, micro-controller-based Temperature and Humidity indicator. Battery life is max. of 1 year with a standard 9VDC alkaline battery. TRH-100 is with magnetic keys for programming parameters, also having MIN./MAX function, which can be seen by using magnetic keys without opening...

The testo 174 mini data logger measures and logs the air temperature and relative humidity in storage rooms and offices continuously without interruption accurately and reliably.

·         Display of current temperature/ humidity value
·...

• Mesa develops, manufactures and markets, high-quality process validation and monitoring instruments and consumables. • Prochem BD 134 Or 121ºC - Ready to use Intended to evaluate the performance of the Air Removal (vacuum) system of Pre-Vacuum equipped Steam Sterilizers at  134 Or 121ºC ...

Turnkey Projects from Design to Supply, Installation, Commissioning and Qualification ( Biotech, High Potent API, Formulation, Nutraceuticals ) ·         Conceptual, Basic and Detail Engineering -Process, Utilities, HVAC & Clean Room, Production Subsys...

The Pharma Servicdes / Lichtenheldt development Department (LDS) accompanies and advises our customers from product idea through galenic development and through the registration into the routine production. For product development and scale up Lichtenheldt has its own dedicated staff and laboratories, ...

Glatt Pharmaceutical Services develops and produces solid pharmaceutical dosage forms. Our focus lies on multiparticulate systems such as pellets, micropellets and granules. Whether you are looking for optimal bioavailablity or taste masking, improved solubility or stabilization of the dosage form, we have...

AUDITING: - Support its clients on Vendor Audit; COMMISSIONING:- Manages and performs commissioning activities for new systems, equipments and facilities; 
TESTING:- Performs the following testing activities using its own instrumentation saving costs and time on tests planning; 
COMP...

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...

Validation of computerized systems (CSV) according to GxP Guidelines has been a basic requirement in the life science industry for many years now. However, as the complexity of the IT landscape and the degree of automation has increased, the effort required to keep compliance has risen as well. Of cour...

Distributed Control & Data Management System is our design approach to bring all the automated systems in plant on a single platform with an operational and Database redundancy. It is an application that helps clients to secure and store the data in system as per their IT policy. The key objectives of ...

Our Electronic Batch Record Software is a one-of-a-kind software application designed to ensure compliance with Good Manufacturing Practices and relevant documentation in the pharmaceutical industry. It can be easily integrated with instruments and equipment to enhance performance and ensure the credibilit...

SES012 STERIND:  AUTOCLAVE STERILISATION CHECK AMPOULES 10^6  Geobacillus stearothermophilus - ATCC NO: 7953(1 BOX X 50 AMPOULES) without Negative Control with COA RESULT 24 HRS 

SES013 STERIND:  AUTOCLAVE STERILISATION CHECK AMPOULES 10^6  Geobacillus stearothermophilus - A...