Development & Validation of Analytical Methods

Development & Validation of Analytical Methods Companies (61)

Development & Validation of Analytical Methods News

Development & Validation of Analytical Methods Products (103)

  • Product Analytical Method Development & Characterization

    We provide support in developing analytical methods using UV-VIS spectroscopy, High-Performance Liquid Chromatography, and Ultra-Performance Liquid Chromatography for the quantification of small molecules and biomolecules. Our particular strength lies in creating robust methods for samples in complex disso...
  • Product Development and Validation of Analytical Methods

    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.
    ...
  • Product Large Molecules Regulated Bioanalysis

    Lambda provides regulated bioanalytical support for large molecules, biologics and biosimilars across clinical development. Capabilities include large-molecule PK analysis, anti-drug antibody assessment, neutralizing antibody testing, pharmacodynamic biomarkers, functional bioassays, immunogenicity assessm...
  • Product Analytical Services & EU Batch Certification

    Method Development and validation
    Stability Studies
    European testing & batch certification

  • Product Highly Potent APIs (HPAPIs) CDMO Services

    ESTEVE CDMO supports highly potent small-molecule API programmes from fit-for-phase process and analytical development through cGMP manufacturing and commercial supply.

    Our dedicated HPAPI capabilities combine specialized R&D, cGMP manufacturing and quality control infrastructure designed to...
  • Product mABS and ADCs

    Characterization & Comparability,​ including method development & troubleshooting​-Deep expertise to assess the physical, chemical, and performance properties of your ADC, with tailored packages to meet the specific needs of each molecule.​

    Release Testing & Stability Studies,​ inclu...
  • Product R&D Laboratory of medical devices | CDMO | Regulatory Affairs

    Over 400 developed recipes, 
    including over 30 medical devices in various classes and indications,
    in 20 pharmaceutical forms - 
    everything starts in the Gofarm's R&D Laboratory.



    In Gofarm's R&D Laboratory our and our clients' ideas take real shapes...
  • Product Custom Formulation Development

    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...
  • Product GMP Analytics

    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
  • Product Clinical Trial Manufacturing, Packaging, Labelling, Serialisation

    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...
  • Product People Solutions - Managed Services

    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...
  • Product Nitrosamine Impurities

    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...
  • Product Laboratory Services

    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...
  • Product KD Pharma lipids APIs and Intermediates

    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
    ...
  • Product Hot Melt Extrusion

    To successfully develop and manufacture your polymer-based delivery systems, like implants and intra-vaginal rings, we have advanced extrusion capabilities in Malmö (Sweden) and Putnam (US Connecticut). The US site is also a center of expertise for Hot Melt Extrusion (HME).

    HME improves the bioa...
  • Product Analytical Services

    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 ...
  • Product Release Testing

    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...
  • Product CDMO

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

    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 ...
  • Product Analytical 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...

Upcoming Events

  • CPHI South East Asia 2026

    QSNCC, Bangkok, Thailand
    08 Jul 2026 - 10 Jul 2026
  • CPHI Korea 2026

    COEX, Seoul, Korea
    25 Aug 2026 - 27 Aug 2026
  • CPHI & PMEC Shenzhen 2026

    Shenzhen Convention & Exhibition Center (SZCEC), China
    16 Sep 2026 - 18 Sep 2026

Pharmaceutical Industry Webinars