Process Validation (Biopharmaceutical Products)

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.

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...

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...

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...

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...

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...

Yamasa corporation offers a wide range of biochemicals products which includes guanosine 5'-diphosphofucose, disodium salt (gdp-fuc, 2na). Contact us for more information.

Yamasa corporation offers a wide range of biochemicals products which includes uridine 5'-diphosphoglucuronate, trisodium salt (udp-glcua, 3na). Contact us for more information.

Yamasa corporation offers a wide range of biochemicals products which includes guanosine 5'-diphospho-d-mannose, disodium salt (gdp-man, 2na). Contact us for more information.

Yamasa corporation offers a wide range of biochemicals products which includes uridine 5'-diphospho-n-acetylgalactosamine, disodium salt (udp-glcnac, 2na). Contact us for more information.

Yamasa corporation offers a wide range of biochemicals products which includes uridine 5'-diphospho-n-acetylglucosamine, disodium salt (udp-galnac). Contact us for more information.

Yamasa corporation offers a wide range of biochemicals products which includes uridine 5'-diphosphogalactose, disodium salt (udp-gal, 2na). Contact us for more information.

Yamasa corporation offers a wide range of biochemicals products which includes uridine 5'-diphosphoglucose, disodium salt (udp-glc, 2na). Contact us for more information.

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

Yamasa corporation offers a wide range of biochemicals products which includes polycytideylate, sodium salt (poly(C), Na). Contact us for more information.

Yamasa corporation offers a wide range of biochemicals products which includes Polyinosinate, sodium salt (Poly(I), Na). Contact us for more information.

Yamasa corporation offers a wide range of biochemicals products which includes Polyinosinate Polycytidylate, sodium salt (Poly(I)・Poly(C), Na). Contact us for more information.