Analytical Development

Choosing the right partner for analytical and biosafety testing is critical in the race to approval. Our BioReliance® Contract Testing Services offer exceptional, risk-mitigating solutions with technical and regulatory expertise, to help bring life-changing drugs to market.

With top expertise in protein analytics, KBI has successfully completed over 3300 analytical projects for more than 300 customers and more than 130 distinct molecules.


Our experience includes antibodies (IgG1, IgG4, IgM, FAb, ADC, Fc fusion), enzymes, cytokines, growth factors, highly glycosylat...

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...

Laboratory services according to GMP and CMC: We provide regulatory-driven, phase-appropriate laboratory services, supporting CMC programs from preformulation to formulation to product release. Among our capabilities are centres of excellence for method development and validation, analysis, stability s...

Solvias provides cGMP-compliant contract analytical services to help you ultimately provide safer products to consumers. We provide a comprehensive range of analytical services to the pharmaceutical, biotech, medical devices and cosmetics industry with similar regulatory requirements for raw materia...

With a team of experienced scientists and a robust toolbox of analytical techniques, Experic can support the life cycle of your oral solid dose and/or inhalation pharmaceutical products. Our laboratory staff provides comprehensive analytical solutions to support the entire spectrum of development and manuf...

Singota solutions offers wide range of services which includes GMP analytical testing.
Studies & Methodologies: • Material Identity • In Process • Product Release • Product Specific Assays • Compendial • Microbial (Endotoxin, Bioburden, Sterility) • CoA Generation • ICH Stability (All ICH...

Method Development and validation
Stability Studies
European testing & batch certification

In response to nitrosamines present in pharmaceutical products, the European Medical Agency (EMA) and the US Food and Drug Administration (US FDA) have published requirements and limits related to nitrosamine contaminants. Therefore Brightlabs has developed and validated multiple methods to determine low l...

We are the world’s leading provider of orally inhaled and nasal drug product design and development services. We enable the seamless translation of pre-clinical development through to clinical manufacture of OINDPs. We do this through our unique processing technologies and formulation development tools....

FUJIFILM Diosynth Biotechnologies is an industry-leading cGMP Contract Development and Manufacturing Organization (CDMO) supporting the biopharmaceutical industry in the development and production of biologics, vaccines and cell and gene therapies. Our focus is to combine technical leadership in process d...

Based on an analytical continuum our testing experts provide solutions all along the value chain from early discovery to clinical trials including method development, validation, quality control, stability studies of the main physicochemical and microbiological testing for innovative and generic products.

Genovior Biotechnology Corporation facility capabilities & current ongoing production lines

We have extensive experience and know-how in the development of oral dosage forms containing spray dried powders. Tablets and capsules are the most common dry powder dosage form. However, other dosage forms such as sachets (bulk powders), vials (for reconstitution) have also be developed by the Upperton team.

ADAPTEK® TECHNOLOGY is the general name for our 4 international patents and expertise in nanotechnology and controlled release systems.This is a transversal technology that allows to develop customized biopolymeric nanohydrogels, allowing the load with different API (drugs, vitamins, growth factors, etc.)....

Pharmaffiliates is providing all the Analytical Services (i.e. Method Development, Method Validation & Transfer, Stability Studies, Contract Analysis, etc)

BioDuro-Sundia’s Analytical Testing team offers high quality analytical services including method development and validation, qualification of reference standards, testing and release studies, stability studies, and CMC dossier preparation services. ...

TECNALIA, experts in Pharmaceutical Development, Scale-up & Pilot Batches Manufacturing, Clinical Trials and Contract ManufacturingPilot

Batches and Registration Batches /
• Manufacture in compliance with the principles and guidelines of GMP for medicinal products.
• Transfer o...

Our analytical experienced team support the pharmaceutical development during every phase of the development process. Analytical development transfer and validation, characterization capabilities, stability analysis, ICH Q3D (residuals solvent risk assesment), ICHQ3C (elemental impurities risk assesment...