Development & Validation of Analytical Methods

Accurate and reliable measurement of drug concentrations and biomarkers in biological matrices is fundamental to drug development success. ResolveMass Laboratories offers GLP-compliant bioanalytical method development and validation for a broad range of analytes — spanning small molecules, large molecules,...

TP&C provides tailored formulation development services for pharmaceutical, OTC and dermo-cosmetic products, adapting each project to target performance, regulatory needs and manufacturing constraints. From concept to scale-up, the R&D teams support partners with formulation optimization, stability...

GMP analyticsQuality control of raw materials, excipients, active pharmaceutical ingredients (APIs), and finished medicinal products
Batch release (EU retest)
Method validation, verification, and transfer
Biopharmaceutical studies
Human and veterinary sectors

Our services for clinical trial batches:
• Manufacturing an tailor-made primary, secondary and tertiary packagingLabelling of primary, secondary and tertiary packaging • Customised labelling incl. blinding/randomisation • IMPD WritingDevelopment and packaging of individual patient kits • Release and...

As a Managed Service Provider, Catalyx delivers dedicated GMP-expert teams to execute defined scopes of work or support critical functions within a client’s business. Led by an experienced team lead, our solutions ensure full alignment with client expectations while providing managed, flexible, and scalabl...

Concerned about nitrosamine impurities in your research? Look no further than Simson Pharma, your trusted source for high-quality nitrosamine impurities at unbeatable prices. Nitrosamine impurities are closely monitored due to their potential health risks, and having accurate standards is vital for an...

Alcami offers fully-integrated analytical method development, method validation and testing solutions for raw materials, API/BDS and Drug Product.Built on a foundation of comprehensive analytical services for pharmaceuticals including biologics, our advanced laboratories and experienced scientist...

We offer our lab services for PSD (particle size distribution) measurements, PSD method development and validation. PSD analysis is done by user laser diffraction systems, microscopic imaging and sieve analysis. 

Lipid Portfolio

Omega-3 APIs

·        Largest producer of omega-3 APIs worldwide

·        Ultra-high purity: EPA up to 99%, DHA up to 95%, tailored ratios
...

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 ...

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: We ...

Coriolis Pharma offers release testing services to ensure that drug products meet their intended target product profile, safety, efficacy, and regulatory standards. Our analytical offerings include both compendial and custom methods for purity, identity, potency, particle and aggregate analysis, polysorbat...

Analytical methods development & validation: We apply a broad range of analytical technologies - including chromatography, mass spectrometry, spectroscopy, biophysical and bioanalytical techniques - across diverse products and methods - to ensure every method is fit for its intended purpose.
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PLD 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 to ...

•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...

Clearsynth is a globally trusted partner for reference standards and research chemicals. We offer over 3,000 nitrosamine impurities, 5,000+ stable isotopes, and 10,000+ drug impurities, encompassing a vast portfolio of more than 325,000 products serving various industries, including pharmaceuticals, clinic...

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, ...

Comprehensive analysis during formulation development and GMP manufacture is vital to ensure that your drug has optimal delivery properties and stability profile as well as supporting your regulatory submissions.

Method Development and validation
Stability Studies
European testing & batch certification

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