Process validation
Process validation Companies (12)
Process validation News
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News Ajinomoto introduces fast track platform for drug product manufacturing
AJILITY is designed to speed novel or existing therapeutics from development to manufacturing and into the clinic. -
News Evotec expands into gene therapy with new Austrian unit
Evotec has established a dedicated gene therapy-based R&D site in Orth an der Donau, Austria with the immediate focus of spearheading a partnership with Japan’s Takeda to support its research projects, the German drug discovery firm said Monday.
Process validation Products (28)
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Product Characterization
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 ... -
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 COMPLIANCE
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... -
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 Drug Products
CARBOGEN AMCIS has developed a comprehensive range of services for the formulation of New Molecular Entities (NMEs) and the reformulation of existing drugs. With a specialization in developing sterile and pyrogen-free parenteral formulations for preclinical and clinical trials (phases I, II and III), CARBO... -
Product ANDA and NDA Technical Support
As part of its commitment to full service support, Avéma Contract 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 com... -
Product Pharma Services / LDS
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, ... -
Product DCDMS ( Distributed Control & Data Management System )
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 ... -
Product Battery Operated Temperature Humidity Indicator
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... -
Product Mini data logger– testo 174
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
·... -
Product Biopharmax Design Engineering Services and Turnkey Projects for Pharmaceutical Industry
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... -
Product Adenosine 5'-monophosphate, free acid (5'-AMP, free)
Yamasa corporation offers a wide range of biochemicals products which includes adenosine 5'-monophosphate, free acid (5'-amp, free). Contact us for more information. -
Product Electronic Batch Manufacturing Record (eBMR)
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... -
Product Adenosine 5'-monophosphate, disodium salt (5'-AMP, 2Na)
Yamasa corporation offers a wide range of biochemicals products which includes adenosine 5'-monophosphate, disodium salt (5'-amp, 2na). Contact us for more information. -
Product Adenosine (Adenosine)
Yamasa corporation offers a wide range of biochemicals products which includes adenosine (adenosine). Contact us for more information. -
Product Extractables & Leachables Testing
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. -
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 Life Science: Computer System Validation
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... -
Product SES012 STERIND: AUTOCLAVE STERILISATION CHECK AMPOULES 10^6 Geobacillus stearothermophilus - ATCC NO: 7953
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... -
Product SDS015 STERIND: Dry Heat Sterilization Spores Strips
SDS015 STERIND: Dry Heat Sterilization Spores StripsBacillus atropheaus .. ATCC NO: 9372 (1box x 100 strips) with COA
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