Analytical method development

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

Method Development and validation
Stability Studies
European testing & batch certification

With a team of experienced scientists and a robust toolbox of analytical techniques and equipment, 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 formulation, development, ...

•Development and validation of analytical methods to ensure accurate quantification, purity assessment, and impurity profiling. 

•Characterization of raw materials, intermediates, and final APIs using techniques such as HPLC, GC, MS, NMR, and XRPD. 

•Stability studies and fo...

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...

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...

Analytical Services: QC Chem/Microbio, stability, etc.

• Control of pharma samples solid state : Identification and quantification of solid state, method development and validation, routine QC. • Analytical techniques available : XRPD, DSC, TGA, DVS, Laser PSD, FTIR, IDR. • All analyses are applicable to toxic samples down to : 50 n...

Physico-Chemical testing
- General identification (TLC, HPLC)
- Assay (UV/VIS, HPLC-UV, GC-FID, LC-MS/MS) and dosage uniformity
- Related substances identification and quantification (HPLC-UV, GC-FID, LC-MS/MS)
- Physical determinations (pH, viscosity, density)
- Moisture...

We have the experience, expertise, and facilities at Sever Pharma Solutions to safely work with your high-potent substances. This includes manufacturing products containing APIs that are ranked in the highest occupational exposure bands (OEB) up to and including OEB6.

Our focus on safety starts ...

Synerlab provides wide range of services which includes development. Contact us for more information.

Analytical services 

In addition to the basic product quality control, the following connected services are offered, which are required throughout the product development or before the market launch of the respective products:

 

GMP for excipients, risk assessment...

KD Pharma’s professional expertise, state-of-the-art assets and proven track record in regulatory compliance allow us to become your preferred CDMO solutions partner.

Your Agile Experts
• Responsive to our customers’ needs in a more dynamic customer-centric way • Adaptive to the most diverse re...

We like to get involved right from the start of a development project and work closely together with our clients and partners on transforming the idea into a product with a solid and commercially viable target product profile (TPP). We set the bar high but always work step by step with a clear focus on...

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

Manufacturing ANALYTICAL DEVELOPMENT
• Monitoring of the first industrial manufacturing batches.
• Characterization of raw materials according to Pharmacopoeia. q...

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...

• Cytotoxic Injection (Liquid , Lyophilized) • ONCOLOGY  • CYTOTOXIC API • EU GMP  • JGMP (Japan) • KGMP (Korea) • PIC/S

We are a GLP lab specialist in vitro permeation testing, including the bioequivalence tests under the EMA draft guideline. We support pharmaceutical companies through bioequivalence studies. Visit our booth and find out more about our R&D dedicated to this topic.

SERVICES Kemwell provides integrated development and manufacturing services for companies that require one-stop solution for mammalian cell-culture based protein therapeutics The team is experienced to undertake end-to-end activities right from cell line development till cGMP clinical and commercial manufa...

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...

Brightlabs has in-house validated methods for the analysis of elemental impurities in accordance to ICH-Q3D. Brightlabs has a unique approach for ICHQ3D, which guarantees quick turnaround times at reduced cost

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...

All Pharmaceutical Reference Standards are supplied with Certified COA along with supporting analytical data like HPLC, Mass, NMR, CMR, UV, IR, TGA, ROI, CHNS.

Neotron Pharma is able to validate analytical methods developed internally or transmitted by the customer using top of the range equipment such as:
- HPLC-UV / DAD / MSMS
- GC-FID / ECD / MSMS (even in Headspace)
- ICP-MS / AAS / AES / OES
- Post-column derivatization
- Particle si...

Famar R&D is offering a complete set of Contract Development services.

• Formulation and process development for Rx, Gx, OTC, Cosmetics (Solids, Semi-solids /liquids dosage forms, Sterile liquids & Lyophilized powders) and Medical Devices • Analytical methods development and validation&nbs...

Where particle size and performance really matters, Upperton have the expertise.
Drug delivery into the lung is one of the fastest growing, yet technically challenging areas of pharmaceutical development. Producing a successful pulmonary drug product requires expertise in formulation development, part...

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.)....

ChemCon’s analytics team takes care of your inquiries if you are looking for ICH-compliant quality control, GMP validation, release analysis, impurity determination, reference standards or answers to other analytical queries. Close, outcome-oriented communication is the key to a successful partnership:...

Avéma offers formulation, process and analytical development support of new or existing products using the most current and effective active ingredients and delivery systems. Our team of scientists bring decades of pre-formulation development expertise to your products, combined with the knowledge of how t...

Lomapharm GmbH provides wide range of services which includes development service. It provides the whole range of control services - from raw material testing to stability testing according to GMP and ICH regulations. One of the main areas of competence and experience is also available for galenic dev...

With extensive, state-of-the-art analytical testing facilities and equipment, our expert teams are able to develop and validate the methodologies required to characterise inhaled delivery platforms, especially DPI, pMDI and nebulised products.

To ensure seamless support for your development...

Accelerating molecules through to proof-of-concept - Simplify early development and accelerate to Proof-of Concept.Proof-of-concept (POC) is a key milestone in the development of a new drug candidate. We understand the transition to POC needs to be fast and cost-effective.With fully integrated capabil...

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...

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.

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. ...

Analytical methods development and validation: Our method development scientists work with a broad range of products, methods, and analytical technologies (chromatography, mass spectrometry, spectroscopy, biophysical analysis, bioanalytical techniques, etc.) to ensure that the method will meet its int...

GVK BIO offers a range of Formulation R&D solutions that include pre-formulation studies, formulation development, analytical R&D, reformulation and stability studies. We can also support clinical supplies and manufacturing of exhibit batches in collaboration with our partners and offer standalone ...

Our analytical portfolio comprises 200+ different techniques – all performed by Coriolis’ experts in-house. Our offering includes:
• Aggregate analytics • Particle characterization • Particle identification • Surfactant characterization • Higher order structure analysis • Funcional assays • Chemi...

Through Recipharm Analytical Solutions™, we support customers with stand-alone analytical requirements. Our analytical development team has experience from developing hundreds of analytical methods every year, supporting development of formulations ranging from powder in capsules and IV solutions to ER tab...

SUPPORT SERVICES FOR OUR CONTRACTED CUSTOMERS • Analytical Development • Validation Support • Regulatory Support • Clinical Supply Services

The Gasporox sensor series GasSpect offers non-destructive Headspace Gas Analysis to be integrated into an inspection machine. The sensors with its highly sensitive laser impresses with performance and precision. The GasSpect series comes in different variations depending on which gas to be inspect...

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.

Through advanced laser imaging techniques, we provide analytical services to support the qualification and validation of spray devices. Testing services on pharmaceutical inhaled drug delivery devices are performed with high-speed imaging to evaluate the dynamic performance of devices by looking at its...

Clearsynth provides a wide range of high-purity NMR solvents designed to ensure optimal resolution and reliable analysis, supporting both research and quality control applications 

Benzene D6 , Chloroform-D , Dimethyl Sulphoxide D6 (DMSO D6) , Methanol D4 , Deuterium Oxide , Tetrahydrofuran...

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....

When you work with Celanese you have access to the right mix of services, support, and proven materials to accelerate your drug delivery program through technical feasibility. The Celanese Development & Feasibility Lab offers formulation development, drug release testing, form factor development, mater...

Our experts have over 30 years of experience in specialized analytical and toxicology assessment for extractable leachable testing. Intertek offers extractables and leachables testing services through GMP-compliant laboratories located in Whitehouse, NJ (USA) and Basel (Switzerland) wit...