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 clients to define their process control strategy to take forward into ma...

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...

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...

Ensure success from an early stage
Selecting cancidates with the highest development success rate • Early-stage stability screening & scoring • Recommendation of the most suitable formulation

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.

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...

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 identificatio...

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...

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, ...

There is much to consider when choosing a sterilization technology. Sterigenics’ expert advisors look forward to working with you to understand and achieve your unique product goals. We offer all major sterilization technologies: Gamma Irradiation, Ethylene Oxide & Electron Beam as well as innovativ...

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

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...

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...

We Make it Work - For Every Molecule. Successful development relies on a deep understanding of a molecule’s unique characteristics. At Samsung Biologics, we have the knowledge and expertise to realize the true potential of your molecule, regardless of its complexity. By taking the right steps through ...

Yamasa corporation offers a wide range of biochemicals products which includes adenosine 5'-monophosphate, disodium salt (5'-amp, 2na). Contact us for more information.

Yamasa corporation offers a wide range of biochemicals products which includes adenosine 5'-monophosphate, free acid (5'-amp, free). Contact us for more information.