CPHI Online is the largest global marketplace in the pharma ingredients industry

  • Products
    0
  • Companies
    0
  • Articles
    0
  • Events
    0
  • Webinars
    0

Method Development, Validation and Transfer

Method Development, Validation and Transfer
Product Description

Kymos Pharma Services, S.L. offers wide range of chemistry, manufacturing & control analytical services in medicinal chemistry which includes method development, validation and transfer. Kymos has comprehensive knowledge in the development and validation of analytical proprietary and non-proprietary methods for excipients, apis, intermediate products and finished products, according to the ich q2 (r1) and fda guidelines and using qbd strategies to improve the results. Their methods are ready for transfer to contract-giver, in compliance with eu-gmp chapter 6, performing a comparative test, a co-validation in two sites or a revalidation. Contact us for more information.

Kymos Pharma Services, S.L.

  • ES
  • 2016
    On CPHI since
  • 100 - 249
    Employees
Company types
Contract Service
Specifications
  • Selling Points
    Product Features; Quality Service
  • Supplied from
    Spain

Kymos Pharma Services, S.L.

  • ES
  • 2016
    On CPHI since
  • 100 - 249
    Employees
Company types
Contract Service

More Products from Kymos Pharma Services, S.L. (22)

  • Residue Depletion Studies & Bioequivalence

    Product Residue Depletion Studies & Bioequivalence

    Kymos Pharma Services, S.L. offers wide range of bionalysis services in medicinal chemistry which includes residue depletion studies & bioequivalence. 

    We validate methods and analyse sample for pharmacokinetics, residue-depletion studies and bioequivalence stu...
  • Stability Studies

    Product Stability Studies

    Kymos Pharma Services, S.L. offers wide range of chemistry, manufacturing & control analytical services in medicinal chemistry which includes stability studies. Kymos provide full service of ich and on-going stability programs for third parties. The services, at client's choice, can include: method tra...
  • Vaccine Potency Assays

    Product Vaccine Potency Assays

    Kymos Pharma Services, S.L. offers wide range of chemistry, manufacturing & control analytical services in medicinal chemistry which includes vaccine potency assays. Suports in the development of potency assay of vaccines for quality control in order to substitute "in vivo" testing. We are able to perf...
  • Bioanalysis of Oligonucleotides

    Product Bioanalysis of Oligonucleotides

    We quantify according to GLP nucleic acids in various biological matrices for you. We develop standardized and reproducible methods that will bring you through FDA/EMA registration. No matter which nucleic acids you develop as therapeutics, biomarkers or similar, we offer you the quantification of your nuc...
  • Bioanalysis of Small Molecules

    Product Bioanalysis of Small Molecules

    Kymos Pharma Services, S.L. offers wide range of bionalysis services in medicinal chemistry which includes bioanalysis of small molecules. Kymos offer bioanalytical method development and validation of innovative small molecules by mass spectrometry. It has the experience of being the selected partner for ...
  • Immunogenicity

    Product Immunogenicity

    Kymos Pharma Services, S.L. offers wide range of bionalysis services in medicinal chemistry which includes immunogenicity. Kymos have develops new bioanalytical methods for immunogenicity studies of proteins and peptides following ema and fda guidelines on immunogenicity of therapeutic proteins. Depending ...
  • Bioequivalence Studies

    Product Bioequivalence Studies

    Kymos Pharma Services, S.L. offers wide range of bionalysis services in medicinal chemistry which includes bioequivalence studies. Kymos are experts in bioanalysis for bioequivalence studies in collaboration with the sponsor and/or the selected clinical phase center. It has a long list of validated bioanal...
  • Percutaneous Absorption

    Product Percutaneous Absorption

    Kymos Pharma Services, S.L. offers wide range of bionalysis services in medicinal chemistry which includes percutaneous absorption. Kymos shows their experience in studies of percutaneous absorption for topical semisolid drug products using vertical diffusion cells (o franz cells). Both in vitro release te...
  • Absorption studies of Dietary Suplements and Phytopharmaceuticals

    Product Absorption studies of Dietary Suplements and Phytopharmaceuticals

    Kymos Pharma Services, S.L. offers wide range of bionalysis services in medicinal chemistry which includes absorption studies of dietary suplements and phytopharmaceuticals. It performs the bioanalysis of active ingredients in biological samples coming from clinical studies of nutraceuticals, medical devic...
  • Analysis of Inhalation drug products

    Product Analysis of Inhalation drug products

    Kymos Pharma Services, S.L. offers wide range of chemistry, manufacturing & control analytical services in medicinal chemistry which includes analysis of inhalation drug products. The devices used for inhaled and nasal drug delivery are collectively referred to as orally inhaled and nasal drug products...
  • Analytical Chemistry

    Product Analytical Chemistry

    Kymos Pharma Services, S.L. offers wide range of chemistry, manufacturing & control analytical services in medicinal chemistry which includes analytical chemistry. Kymos has wide experience in performing analytical tests of raw materials, apis, intermediate products, finished products, packaging materi...
  • Batch Testing & Batch Release

    Product Batch Testing & Batch Release

    Kymos Pharma Services, S.L. offers wide range of chemistry, manufacturing & control analytical services in medicinal chemistry which includes batch testing & batch release. Features: apis certificate of analysis according to the relevant pharmacopoeias, individual parameter determination to be incl...

Kymos Pharma Services, S.L. resources (2)

  • News Kymos Acquires Germany’s Prolytic

    Kymos, a Contract Research Organisation (CRO) and member of CataloniaBio & HealthTech, has bought German company Prolytic GmbH in order to strengthen its activity in the biologics and advanced therapies market. The company previously acquired Italian firm Pharmaprogress in 2016.
  • Brochure KYMOS: Adding Value to Biopharma

    KYMOS recently had the pleasure to lead a TV program series about the importance of outsourcing service providers like ourselves in the provision of medicines. Since the outbreak of COVID-19 the general public is paying much more attention to the biopharmaceutical industry and the challenges of conducting drug development, manufacturing, quality control and supply in the midst of a global pandemic. We invite you to watch this 2-minute English video and celebrate society's rising awareness of the key role played by the pharma and biotech sectors in our day-to-day lives.

Frequently Viewed Together

  • Product Excipients Formulation Development Support


    Excipients play a central role in the drug development process, in the formulation of stable dosage forms and in their administration. Though excipients were at one time assumed to be “inactive” ingredients, it is now understood that excipients can have an important impact on the pharmaceutical...
  • Product Hexane(HPLC grade)

    Package size including 1L/bottle,2.5L/bottle,4L/bottle.Always keep 1000bottles in stock.
  • Product Elemental Impurities

    In light of the growing interest of the pharmaceutical world on the issue of determining Elemental Impurities in accordance with tables 1, 2a, 2b and 3 of the ICHQ3D, Neotron Pharma laboratory, thanks to its decades of experience in the analysis of metals, has developed a series of analytical proposals to ...
  • Product GMP-Support: Qualification / Validation / Consulting

    Quasaar does not see itself as "processing office" of service contracts.

    As an outsourcing partner, Quasaar also focuses on problem solving, increasing efficiency and process optimization, including on-site consulting and project management.
    Our expertise includes i.a. following topics: ...
  • Product J.T.Baker® Direct Dispense packaging system

    Enhance the effectiveness of your products and streamline your biopharmaceutical manufacturing processes with the J.T.Baker® Direct Dispense packaging system. This novel packaging platform makes it easy to deliver powdered performance materials and excipients directly to your process, whether you are using...
  • Product Disease Activity Models/Tissue Culture

    MedPharm has developed proprietary models relevant for major disease areas such as psoriasis, atopic dermatitis, onychomycosis and continue to develop new ones through our dedicated innovation group. These sophisticated ex vivo experiments provide additional confidence to clients and their in...
  • Product Validation

    Our team of experts will prepare necessary protocols incorporating all critical parameters


    Process Validation:

    PharmEng professionals possess experience in validating pharmaceutical and biopharmaceutical manufacturing processes. Our team of experts will prepare necessary protocols i...
  • Product Regulatory Testing and Research based services for Pharmaceuticals, Chem...

    1) Analytical Testing Of Pharmaceuticals & Cosmetics2) Biotechnological Services
    3) Microbiological Services
    4) Bio - Compatibility Studies of Medical Devices(As per ISO 10993USFDA and MHLW Guideline)
    5) Preclinical & Toxicological Services
    6) Phytochemical & AYUSH Testing Se...
  • Product Sterile drug product CDMO services

    Thermo Fisher Scientific's flexible aseptic manufacturing and sterile fill finish solutions for your molecule's unique needs and challenges will enable success in early development, late-phase, and commercial manufacturing.

    Thermo Fisher offers extensive sterile product development and commercial ...
  • Product Analytical Development and expertise

    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...
  • Product Analytical Services

    From a drug product's first raw materials to its release-ready batches, our experts rigorously evaluate and verify a product's quality at key steps throughout the manufacturing process. Analytical services include material testing to verify product quality from the early stages of development, cGMP-com...
  • Product SOFTGELS

    At Softigel, we offer much more than traditional softgels, including everything from a single unit dosage form, to multiple delivery systems in a single dose. Softgels are an effective delivery system for oral drugs, especially those with low solubility and/or permeability (BCS Classes II, III and...
  • Product Electron Beam

    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...
  • Product Analytical Services

    Our Analytical Services encompass critical aspects of drug development and manufacturing, beginning with Analytical Testing to ensure product quality, employing advanced instrumentation and experienced teams to facilitate compliance. We excel in Method Development & Validation, utilizing HPLC and UHPLC...
  • Product Drug Product Development

    We support our clients from early-stage research and preclinical phase to and beyond market approval by providing comprehensive development services, including 

    • Developability assessment • Pre-formulation screening • Formulation development • Lyophilization process development • Forced d...
  • Product Ph. Eur. Reference Standards

    https://store.edqm.eu/index.html

  • Product NETWORKING OF Excellence and innovation of the health sector. Made in Fr...

    A team of experts serving the network.
    POLEPHARMA stimulates industrial and economic development of actors of the French first pharmaceutical sector with actions that promote competitiveness, innovation and attractiveness to the advantage of the job market.

  • Product Analysis Service

    Lomapharm GmbH provides wide range of services including analysis service. It involves chemical and physical analysis of raw materials, intermediate and finished products according to national and international specifications as well as customer-specific information (microbiological purity, stability t...
  • Product Netpharmalab Consulting Services

    Contract Research Laboratory. Analytical Services (physicochemical analysis, microbiological analysis and stability studies) and EU Import Lab.
  • Product Analytical Techniques

    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.
  • Product Pantoprazole Sodium

    It is a digestive system medication suitable for the treatment of acute upper gastrointestinal bleeding such as duodenal ulcers, acute gastric mucosal lesions caused by gastric ulcers, and compound gastric ulcers.
  • Product Quality Management

    If you trust in BioChem, you are in the best of hands, because you work together with a quality-tested full service provider. Our high-quality standards are also regularly confirmed by the authorities during inspections.


    BioChem is your quality approved full-service provider: • Ma...
  • Product Laser Micromachining Services & Systems

    From pinholes in stainless steel discs to complex arrays in semiconductor guide plates, we provide a wide range of ultra-high precision laser drilling, cutting, milling, scribing and ablation contract services (and systems) for numerous applications in industry & academia. With over 45 years of experie...
  • Product Compliance Management

    PharmSol does not limit itself only to offering Audits, but we expand our solution offerings to ensure complete Compliance at the client's site. Towards obtaining GMP Certification from Europe, United States or WHO, PharmSol has a very effective, systematic and rational approach in providing solutions effi...
  • Product Nitrosamine Impurity Testing

    Nitrosamine - testing for its impurities: Nitrosamine impurities such as N-nitrosodimethylamine (NDMA) continue to be an area for concern as highlighted by the US FDA and other regulatory authorities. At Intertek we believe flexible solutions are the way forward to overcome technical challenges and ac...
  • Product Solid & Liquid Dose Drug Manufacturing & Development

    From OTC and Rx to diagnostics and dietary supplements, Avéma manufactures a full range of solid and liquid dose products, all manufactured under strict FDA guidelines and cGMP compliance. With an ever-growing portfolio of innovative formulas and a diverse mix of state-of-the-art equipment, our offerings a...
  • Product Commercial Mass Spectrometry Services

    Mass spectrometry is among the most powerful analytical techniques available for protein characterization. KBI's state-of-the-art mass spectrometry core facility delivers unparalleled structural characterization services to our clients. 
    Our expert team brings decades of experience in protein and p...
  • Product Analytical development

    Alcami offers a fully-integrated analytical method development, method validation, and testing solution with a full complement of advanced analytical and information technologies. From Alcami's electronic laboratory notebook (ELN) data collection system to its integration with our formulation development, ...
  • Product Physical Sciences - Preformulation & Solid State Services

    Almac's Physical Sciences groups' comprehensive range of services and expertise will help strengthen the success of your product. Identifying and consistently producing a drug in its optimal physical form is vital to any successful drug development programme. It also avoids the need for bridging toxicologi...
  • Product Analytical Development

    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. ...
  • Product Quality Control

    Our quality control department offers a broad range of services from incoming goods testing, in process controls to release of final product and stability testing. Our workflow ensures that all products are safe for market release and simultaneously functions as a feedback tool to help in the optimizat...
  • Product Formulation of lyophilized products

    A correct formulation means greater stability of the active ingredient and provides protection against the stress suffered during the lyophilization process itself.

    The selection of the appropriate excipients is really important in the development of a freeze-dried product.
  • Product Track & Trace Pharma Compliance Solution

    The most modular, flexible and comprehensive solution covering Track & Trace compliance at all levels: enterprise (level 4), production plant, packaging line and warehouse, to ensure traceability compliance for EU-FMD, DSCSA and any other regulatory requirement for pharmaceutical products. A platfo...
  • Product Highly Potent Pharmaceutical Principles

    Olon relies on one of the most extensive expertise in handling highly potent pharmaceutical principles at global level, has raised the level of containment up to the actual standards and very large scale putting in place a set of primary and secondary containment designed to avoid the active substances...
  • Product Merieux NutriSciences | Extractables and Leachables studies

    Download our brochure: https://bit.ly/4dzryoA

    Pharmaceutical packaging can release chemicals into the drug product that can not only impair its effectiveness, but also be harmful to the patient. Similarly, medical devices can undergo leaching processes during their use that could negatively affec...
  • Product SANAL® SQ Pharmaceutical Sodium Chloride (API)

    SANAL® SQ Sodium Chloride Pharmaceutical Quality is our chemically pure product which is suitable for all pharmaceutical applications. Additionally this product is suitable for laboratory testing and chemical applications in manufacturing procees - This product comply with American Chemical Socie...
  • Product Validation of AI and non-AI technologies for Life Science companies

    We specialize in AI and non-AI Computer System Validation, equipment validation, utility qualification, and IT/OT infrastructure qualification. Our services comply with the regulatory standards of the EMA, FDA, WHO, ANVISA, and other key Life Science authorities across Europe and the Americas. We are a ...
  • Product LNPs production services by microfluidics

    We offer method development services for the production of lipid nanoparticles LNPs using the microfluidics platform Sunshine from Unchained Labs.

  • Product VialArch

    The Gasporox sensor module VialArch offers non-destructive Headspace Gas Analysis to be integrated directly onto the production line or into an inspection machine.

    This unique laser-based solution is installed on the production line for 100% quality inspection and container closure ...
  • Product Reference Standards

    Pharmaffiliates is Supplying all the Pharmacopoeial Reference Standards (i.e. USP, EP, BP, IP, JP).Apart from this we offer Pesticide Standards, Phyto-chemical Standards, Food & Environmental Standards, etc.
    For more details please send your enquiry on marketing@pharmaffiliates.com
  • Product cGMP Manufacturing

    1. Manufacturing facilities ensure: 1) Production flexibility at various scale 2) Total Production Capacity: 726 m3 including pilot production 3) Potent compound manufacturing (OEL Category 3A, CPT 1 Mug/m3) 2. Various Analytical Capabilities: 1) cGMP QC lab with HPLC, UPLC, GC, LC-MS, GC-MS, NMR, X...
  • Product Research & Development

    Discovery - Biology, Lead Optimization, Libraries, Synthetic & Medicinal ChemistryDevelopment - Chemical Process R&D, Fermentation, Formulation Development, High Potency, Kilo Lab & Small Scale Manufacturing, Lipid Nanoparticle, Method Development/Material Science, Rare/Orphan, Separation Scien...
  • Product Method Validation & Transfer

    Pharmaceutical testing services during and after drug development from QACS ensure GMP compliance and product safety. Method validation studies aim to demonstrate analytical suitability of procedures according to their intended use/purpose. QACS transfer method protocols ensure, that results generated by s...
  • Product UTPVision LAT 313 ACCREDIA

    The UTPVision LAT 313 is a calibration centre accredited by ACCREDIA and it's able to issue calibration certificates with the guarantee of metrological traceability to the International System of Units.
    Discover more: https://utpvision.com/it/certificazioni-accredia/
  • Product Wasdell Manufacturing

    Wasdell's specialised pharmaceutical manufacturing facilities in the North East and the East Midlands are MHRA approved for the manufacture of non-sterile oral liquids with the capability and capacity to extend its services to other dosage forms. We can support the manufacture and packaging for cl...
  • Product QMS Authoring and Licencing Support

    We can help you design and implement effective quality management systems that comply with current EU and UK GxP standards.

     An effective QMS will consist of all of the business processes, personnel responsibilities and standards including manuals, policies and procedures required to...
  • Product Recipharm Analytical Solutions™

    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...