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...

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 ...

This Data Logger /scanner Uses latest micro controller based technology for better accuracy. 8 Channel fixed input for all thermocouple, J, K, R, S, T, E, B, N programmable by users, and Fixed Inputs for RTD (PT-100), 4-20mA, 0-10VDC factory settable. 
Easy on-line field calibration by front p...

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...

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

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...

We work with our clients and provide them end-to-end solutions from design to implementation of their requirements. With a dedicated set of engineers we take care of the overall project detailing, end to end for Distribution Control System.  We have a dedicated team available, experienced in mult...

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...

Yamasa corporation offers a wide range of biochemicals products which includes cytidine 5'-diphosphate, trisodium salt (5'-cdp, 3na). Contact us for more information.

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