GMP and CMC Laboratory Services

Product Description

We provide regulatory-driven, phase-appropriate laboratory services in support of CMC programs seeing you through pre-formulation, formulation and product release. Our capabilities include centers of excellence for method development and validation, analysis, stability studies, extractables and leachables, solid state characterization, cGMP quality control testing and cGMP batch release testing. Our teams have specialist expertise for complex medicines and drug delivery systems such as inhalation drug product development for pulmonary and nasal products or biologic therapeutics.

Intertek Analytical Services

  • US
  • 2017
    On CPHI since
  • 4
    Certificates
  • 5000+
    Employees
Company types
CMO/CDMO
Contract Research Organisation (CRO)
Contract Service
Primary activities
Analytical Services
Biopharmaceutical
Contract Research Organisation
Laboratory Services
Medical Devices
Packaging & drug delivery
Specifications
  • Details
    We provide regulatory-driven, phase-appropriate, CMC laboratory and GMP pharmaceutical laboratory services. Our expertise ensures sufficient information for your Investigational New Drug (IND), Abbreviated New Drug Application (ANDA) and New Drug Application (NDA) filings. This is achieved through analysis services, pre-formulation and solid-state characterisation, method development and validation, stability studies, pharmaceutical impurity analysis, extractables and leachables and GMP batch release testing. Our scientists are adept at applying advanced technology in GMP compliant analytical development programs. 
  • Selling Points
    Experienced Technicians; International Approvals/Standards; Prompt Delivery; Quality Service; Located in Whitehouse, New Jersey, USA, is a contract consulting analytical research and development laboratory and Good Manufacturing Practice (cGMP) compliant facility. We specialize in method development and validation, stability, trace organics, elemental impurities, and quality control testing.
  • Supplied from
    Australia; China; India; Switzerland; United Kingdom; United States

Intertek Analytical Services

  • US
  • 2017
    On CPHI since
  • 4
    Certificates
  • 5000+
    Employees
Company types
CMO/CDMO
Contract Research Organisation (CRO)
Contract Service
Primary activities
Analytical Services
Biopharmaceutical
Contract Research Organisation
Laboratory Services
Medical Devices
Packaging & drug delivery

More Products from Intertek Analytical Services (7)

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    Product Trace Metals Testing and Elemental Analysis

    Our experienced analysts apply a strategic approach to sample preparation for difficult samples and a range of analytical technology, relevant to your needs, including inductively coupled plasma – mass spectrometry (ICP-MS) or inductively coupled plasma – optical emission spectroscopy (ICP-OES) or ion chro...
  • Stability Testing

    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...
  • Extractables and Leachables Testing

    Product Extractables and Leachables Testing

    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...
  • Inhalation Drug Product Development Services

    Product Inhalation Drug Product Development Services

    Our pharmaceutical auditing and management services give you a transparent view of your supply chain enabling you to identify and mitigate the intrinsic risks in your operations, supply chains and business processes. Through our shared audit programs, delivered by our global network of specialist ...
  • Bioanalysis Services

    Product Bioanalysis Services

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  • Clinical Trials

    Product Clinical Trials

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  • Pharmaceutical and Healthcare Consulting Services

    Product Pharmaceutical and Healthcare Consulting Services

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Intertek Analytical Services resources (6)

Frequently Viewed Together

  • 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 Analytical Services

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  • 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 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 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 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...
  • 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 Analytical Services

    With 55+ years of experience, our expert teams develop 1,000+ analytical methods and validate 250+ methods annually. Drawing upon an extensive range of analytical technology, combined with a wealth of analytical knowledge, we can add real value to your drug development and commercialisation programs....
  • Product Outsourcing

    Patheon by Thermo Fisher Scientific has a broad manufacturing platform for pharmaceutical and biologic products which provides sustainable solutions for mammalian cell-based and microbial-based manufacturing, green chemistry R&D and manufacturing technologies, and finished dosage production of biopharm...
  • Product Polymer-based delivery systems

    Polymer-based dosage forms continuously administer the drug to the patient for an extended period, varying from weeks to years. These controlled-release products are very suitable for specific indications, patient populations, and drugs due to the long duration of action, avoidance of first-pass metabolism...
  • Product Disease Activity Models/Tissue Culture

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  • 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 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 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 GALENIC DEVELOPMENT

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

    GALENIC DEVELOPMENT
    • Preformulation studies.
    • Design and galenic develop...
  • Product Residual Solvents and OVI Testing

    We provide expert determination and identification of residual solvents in pharmaceutical articles, helping customers ensure that residual solvents have been reduced to acceptable levels in drug products, drug substances and excipients. Often it is prudent to ensure residual solvents are controlled for all...
  • 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 Highly Potent Pharmaceutical Principles

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  • Product Polysaccharides analysis

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  • 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

    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 Celanese Development & Feasibility Lab Services

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  • Product EVs extracellular vesicles characterization services

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  • 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 Recipharm Analytical Solutions™

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  • Product European Pharmacopoeia Supplements 11.6 to 11.8

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  • Product Nitrosamine and Drug Impurities | Testing and Analytical Services

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  • 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 Analytical Services & EU Batch Certification

    Method Development and validation
    Stability Studies
    European testing & batch certification

  • Product Analytical Services

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  • Product Hexane(HPLC grade)

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

    Method development and phase appropriate validations to support clinical and commercial programsCompendial Testing
    Raw Material Testing
  • Product Pantoprazole Sodium

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  • Product Excipient Quality Testing and Selection Services

    Excipient testing, composition and variabilityExcipients are either natural / naturally derived or synthetic / semi-synthetic. In all cases the exipients are obtained through chemical processing of a raw material source that usually has an animal, vegetable or mineral origin.

    ...
  • 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 Analytical Services for Particle Size Distribution

    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. 
  • Product Analytical Services

    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, ...
  • 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 Extractables and Leachables Testing

    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...
  • Product Extractables & Leachables

    There are many contaminants that could be released inside a drug during the production process or by contact with the packaging material. Neotron Pharma will be able to support you from the study of Extractables, to the toxicological evaluation up to the control of the Leachables. What distinguishes us is ...
  • Product Bioanalytics/Molecular Biology

    Excerpt from the range of services offered by our bioanalytical/molecular biological department:

    • determination of mycoplasma • biological contamination testing • determination of content and identity of nucleic acids • determination of biological activity
    • protein/antibo...
  • 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 Contract Development Services

    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...
  • 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.
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    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.

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