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Medical Devices

Medical Devices
Product Description

The EU Medical Device Regulation (MDR) requires a more stringent characterization of products in the Medical Device field. The MDR is madatory for all new products and existing products have to comply by May 26th 2020. Tentamus Pharma Labs are equipped to support you in fulfilling MDR requirements. Biological endpoints (e.g. haemocompatibility, cytotoxicity, genotoxicity, irritation, etc…) as well as chemical characterization (e.g. extractable & leachable studies, etc…) is available at our laboratories. In addition to these analytical tests, medical testing for stents & stent graft, vascular graft, catheters, heart valves and other devices is available at Tentamus Pharma Labs. Contact us and arrange a meeting with our experts to learn more about our capabilities.

Tentamus Group

  • DE
  • 2017
    On CPHI since
  • 1000 - 4999
    Employees
Company types
Contract Service
Primary activities
Analytical Services
Specifications
  • Supplied from
    Austria; Germany; United Kingdom

Tentamus Group

  • DE
  • 2017
    On CPHI since
  • 1000 - 4999
    Employees
Company types
Contract Service
Primary activities
Analytical Services

More Products from Tentamus Group (6)

  • Pharmaceutical Products

    Product Pharmaceutical Products

    Bringing a pharmaceutical product to the market entails many complex, time consuming and expensive activities. Analytical expertise is a cornerstone in this development process. Tentamus Pharma Labs can support our customers throught the entirety of the development process and commercialization by prov...
  • Biomolecules and ATMPs

    Product Biomolecules and ATMPs

    Biomolecules like antibodies have revolutionized the pharmaceutical industry during the last decade and new products (e.g. Advanced Therapy Medicinal Products – ATMPs) are evolving in clinical studies and on the market. Tentamus Pharma Labs are among the leaders of analytical support for these product ...
  • Microbiology

    Product Microbiology

    Microbiological tests are mandatory for non-sterile and sterile pharmaceutical products as well as medical devices. Tentamus Pharma Labs provide all standard test methods in this field and support your products in development or commercial phases. For non-sterile products, microbial enumeration tests (...
  • Instrument-Based Analytics

    Product Instrument-Based Analytics

    The pharma laboratories within the Tentamus Group are equipped with state of the art analytical instruments offering an unparalleled array of analytical and bioanalytical services. The range covers simple Pharmacopeia methods (e.g. Ph.Eur, USP) to very complex analyses of biomolecules. We offer all kin...
  • Physico-Chemical. Analysis

    Product Physico-Chemical. Analysis

    Physico-chemical methods are required in a range of products and compounds such as excipients, API’s, bulk material and finished products.  Product characterization methods are often mandatory requirements within compendial monographs e.g Ph.Eur, USP, JP, BP. etc.  as well as individual Marketi...
  • Medical Cannabis

    Product Medical Cannabis

    Medical Cannabis is a rising star in the pharmaceutical arena. Research indicates, that it might open new ways in alleviating and treating severe conditions in a variety of indications. One of the biggest challenges for companies in the field are regulatory and analytical requirements of the pharmaceut...

Frequently Viewed Together

  • 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 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 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...
  • Product MasterSense™ Smart Peristaltic Pumps

    NEW integrated sensor technology, intuitive touchscreen and MasterflexLive® remote monitoring for the biopharma industry of tomorrow
  • Product Nitrosamine Detection

    We provide Method Development and Method Validation for new analytical methods or Method Transfer for Routine Testing according to existing validated methods for raw materials and final products. QACS is GMP/GLP certified.
    • performed with UPL...
  • 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 Merieux NutriSciences | Nitrosamines analysis on pharmaceutical products

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

    Thanks to the long-standing experience, Mérieux NutriSciences has been developing various strategies and approaches for the determination of nitrosamines residues in different matrices through sophisticated mass spectrometry combined with a pool of ex...
  • 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 Research & Development

    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...
  • 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 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 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 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 Syringe and Vial Filling for Clinical and Commerical

    Lifecore’s experts have gained the know-how to build processes around your requirements for smooth scale-up and high-quality manufacturing.

    Whether we’re your primary partner or a secondary source for manufacturing, we ensure you're fully satisfied with the final produ...
  • Product Netpharmalab Consulting Services

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

    Formulation Development- Cosmetic products
    - Medical devices (skin and mucous membranes)
    - Oral supplements
    - Veterinary products
    - Biocidal products
    - Topical medicines

    Stability tests - evaluation of the stability of cosmetic products, medical devices, food supplements and bioci...
  • Product Research & Development Capabilities

    PHT International Inc. offers a wide range of services which includes research & development capabilities. Features: it includes process development, process improvement, sample repackaging, sample production, sample analysis. Contact us for more information.
  • 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 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 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 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 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 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 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 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...
  • 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 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 R&D Services

    Our R&D Services are categorized into 8 streams: • Material Science Services

    • Metal and Organic Scavenging Screening Services

    • Organic Synthesis Services

    • Catalysis Services

    • Process Services

    • Chromatography and Purification Services

    • Method D...
  • Product Hexane(HPLC grade)

    Package size including 1L/bottle,2.5L/bottle,4L/bottle.Always keep 1000bottles in stock.
  • 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 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 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 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 Biologics Characterization

    SGS’ range of services dedicated to biopharmaceutical product characterization bring the most recent developments in testing technology to companies across the globe. In 2010, SGS acquired the M-Scan Group, the world leaders in the application of advanced mass spectrometry
    techniques for protein and c...
  • Product Stability Testing

    With a network of ICH stability storage facilities in the UK, US and Australia, we offer an extensive capacity and a range of conditions including climatic walk-in chambers, cabinets and refrigerated as well as freezer storage, covering all ICH stability conditions. These are fully controlle...
  • 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 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: ...
  • Product Analytical Services

    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...
  • Product Gene Therapy Characterisation and Release Testing

    Characterization and release testing of gene therapies: supporting CMC requirements for IND applications and commercial release through expert analysis and stability testing. We provide method development and validation to meet your milestone and regulatory requirement and help you to confirm identity a...
  • Product Pharmaceutical Deformulation / Reverse Engineering

    Our experience in excipient characterization and deformulation of pharmaceutical formulations gives us the opportunity not only to identify and quantify individual excipients in a complex pharmaceutical formulation, but often also confirm the excipient grade, excipient quality and sometimes even the excipi...
  • Product Services - Lab analysis

    We offer the quality standards that we apply to our own environment, machines, solutions and processes as services to our customers as well.

    We make continuous investments in our specialist expertise. Quality assurance is the focus of our work. To ensure that we can meet your requirements r...
  • Product Certification of Suitability (CEP)

    Book a private, one-to-one session with the Certification team to discuss issues such as the CEP procedure, CEP applications or inspections, please complete the online form and the team will be in contact regarding an appointment. 

    Please book using this url: 
    https://www.edqm...
  • Product Core Technologies and Services

    • API / GMP Manufacturing • Rapid Process Development, Flawless Upscaling, and Economy of Scale-Production  • Simulated-Moving Bed (SMB) Chromatography  • Heterocyclic, Hazardous and Malodorous Chemistries • Organometallic and Cryogenic Chemistry • Transition-Metal Catalysis • High-Pressur...
  • Product Integrated offerings

    Alcami is a Us-based, contract development, testing, and manufacturing organization for pharma and biotech companies. Our goal is to support our clients in making their projects go from potential to reality day-after-day.
    Core Capabilities:Sterile-fill finish development and manufacturingO...
  • Product Analytical Services - Inhaled Products

    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...
  • Product Method Validation

    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...
  • Product Drug Substance Services

    CARBOGEN AMCIS provides comprehensive Drug Substance services, offering expertise in process development, scale-up, and manufacturing of active pharmaceutical ingredients (APIs). With state-of-the-art facilities, the company specializes in high-potency compounds, including cytotoxics, and delivers solu...
  • Product EVs extracellular vesicles characterization services

    Alfatestlab is equipped with the latest technology platform to provide rapid, reliable and accurate characterization of EVs following MISEV 2023 guidelines. Based on Nanoparticle Tracking Analysis (NTA - Nanosight) and Single-Vescicle Multiparametric Analysis (Leprechaun), our services for EVs of...
  • 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...