Process validation

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 ...

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...

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...

Are you tired of spending excessive time and resources on the procurement process for your pharmaceutical or life sciences company? Do you have to use service providers outside of your regional reach, leading to physical back and forth of goods in the supply chain that is unsustainable often? Introduci...

For pharmaceutical, biotech, and medical device manufacturers, Quality Management Systems (QMS) are the foundation for enabling the organization to operate in a compliant manner. The QMS establishes the path to compliance for the company and enables sustainable systems that meet the demands of re...

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...

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...

By the end of 2017 we will have a MHRA, GMP licenced laboratory. We will be offering a wide range of services for routine Quality Control analysis including QC release testing, method validation and stability analysis (analytical and microbiological). We work to the highest standards of GMP and GLP with r...

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.

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, ...

Development & Scale Up:
At Pillar5, our agile technical services team can lead your project through any stage of the development process, from pilot scale and scaling up through to commercialization.

Technical Support and Service:
Pillar5 is your partner in the formulation, devel...

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...

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
·...

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...

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

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...

The validation of a new GxP software is only one part of a vast deployment process. Preparation in the form of new processes, validation documentation, user management systems, life cycle management and training is always needed to ensure fresh software packages are fully compliant. At Zamann Ph...

The compliance environment of the pharmaceutical and life science industry can offer very complex challenges. One issue is optimizing workplace technologies in the areas of Business Process Changes, Validation, and general GxP Compliance. At the same time, these challenges must be balanced with the develop...

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 ...