GMP and CMC Laboratory Services

GMP and CMC Laboratory Services
Product Description

Laboratory services according to GMP and CMC: We provide regulatory-driven, phase-appropriate laboratory services, supporting CMC programs from preformulation to formulation to product release. Among our capabilities are centres 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 expertise with complex medicines and drug delivery systems such as inhalation drug product development for pulmonary and nasal products – or complex medicines such as peptides, monoclonal antibodies, proteins, oligonucleotides, mRNA, vaccines, and gene therapies.

To learn more, visit our website: 

www.intertek.com/pharmaceutical/gmp-cmc-laboratory

Read more Show less

Intertek Analytical Services

  • GB
  • 2015
    On CPHI since
  • 4
    Certificates
  • 1000 - 4999
    Employees
Company types
CMO/CDMO
Consultancy
Contract Research Organisation (CRO)
Contract Service
Drug delivery device Supplier/Manufacturer
Manufacturer/Innovator
Primary activities
Analytical Services
Contract Research Organisation
Laboratory Services
Medical Devices
Packaging & drug delivery
Supply Chain
View company profile
Categories
more categories Show less
Specifications
  • Selling Points
    Experienced Technicians; Quality Service; Reputation
  • Model
    GMP LABORATORY SERVICES
  • Supplied from
    Australia; France; India; Switzerland; United Kingdom; United States
More specifications Fewer specifications
Sales Markets
Show more Show less

Intertek Analytical Services

  • GB
  • 2015
    On CPHI since
  • 4
    Certificates
  • 1000 - 4999
    Employees
Company types
CMO/CDMO
Consultancy
Contract Research Organisation (CRO)
Contract Service
Drug delivery device Supplier/Manufacturer
Manufacturer/Innovator
Primary activities
Analytical Services
Contract Research Organisation
Laboratory Services
Medical Devices
Packaging & drug delivery
Supply Chain
View company profile

More Products from Intertek Analytical Services (99)

  • Vaccine Characterization, Delivery and Bioanalytical Support

    Product Vaccine Characterization, Delivery and Bioanalytical Support

    Our vaccines development experts provide a suite of services supporting the analysis, delivery, quality control of process and batch release samples and stability studies. We have support the development of a range of vaccines including mRNA, protein, glycoprotein, DNA, carbohydrate, lipopolysaccharide, li...
  • Intertek Pharmaceutical Services

    Product Intertek Pharmaceutical Services

    Intertek's pharmaceutical contract laboratory services, regulatory assistance, and supply chain assurance deliver quality and safety to meet your unique pharma and biopharma outsourcing needs. We bring quality and safety to life!

    With our pharmaceutical experts working with you at every ...
  • Biopharmaceutical Characterisation and Testing Services

    Product Biopharmaceutical Characterisation and Testing Services

    Characterization and testing of biopharmaceuticals: Using our expert's insight into a biologic's structure, physicochemical properties, potency, and impurity profile, we help you meet your development milestones.

    A range of expertise is available, including assessment of structure...
  • Pharmaceutical Auditing Services

    Product Pharmaceutical Auditing Services

    Auditing services for the pharmaceutical industry: Our pharmaceutical audits are conducted in accordance with the relevant regulatory texts or standards, including GMP, GDP, GLP, GCP, and GVP. We also audit against IPEC guidelines for Pharmaceutical excipients, ISO 22716 (Cosmetics — Good Manufactu...
  • Inhalation Drug Product Development Services

    Product Inhalation Drug Product Development Services

    Services for the development of inhalation drugs: Our team have over 30 years of experience supporting our clients' product development for orally inhaled or nasal drug products (OINDP). This includes formulation, stability, testing, product performance testing, in vitro bioequivalence studies, CMC...
  • Drug Stability Testing and ICH Storage Outsourcing

    Product Drug Stability Testing and ICH Storage Outsourcing

    Testing of pharmaceutical stability and ICH storage outsourcing: Our extensive capabilities cover all ICH conditions (or custom conditions), including climate control walk-in chambers, cabinets, refrigerated and freezer storage that are fully monitored and controlled, with backup units at every locatio...
  • Oligonucleotide Analytical Development Services

    Product Oligonucleotide Analytical Development Services

    Analytical development services for oligonucleotides: For oligo-based drugs, our capabilities range from GLP bioanalysis to GLP/cGMP characterisation. We support product development, from quality control testing of amidite starting materials and early stage product characterization through to GMP batch r...
  • Bioanalytical Services (GLP/GCP)

    Product Bioanalytical Services (GLP/GCP)

    Services for Bioanalysis (GLP/GCP): In our state-of-the-art facilities, we provide GLP/GCP method development, validation, method transfer, sample analysis and pharmacokinetic and toxicokinetic support, along with automated data collection and reporting systems. Over the past 20 years, we have supported...
  • Development and Validation of Analytical Methods

    Product Development and Validation of Analytical Methods

    Analytical methods development and validation: Our method development scientists work with a broad range of products, methods, and analytical technologies (chromatography, mass spectrometry, spectroscopy, biophysical analysis, bioanalytical techniques, etc.) to ensure that the method will meet its int...
  • Formulation Development including Inhaled Products

    Product Formulation Development including Inhaled Products

    Inhaled products and formulation development: The development of drugs using experimental design approaches with integrated stability testing and storage is available from us. Our formulation specialists can provide a wide range of formulations in a timely and cost-effective manner in order to identify t...
  • Nasal Drug Development

    Product Nasal Drug Development

    Development of nasal drugs: Scientists from our nasal drug development team provide method development, validation, and testing services to help you optimise the performance of your aqueous, powder, and propellant-driven nasal drug products. Conducted in Good Manufacturing Compliant (GMP) laborato...
  • Extractables and Leachables Testing Services

    Product Extractables and Leachables Testing Services

    Testing for extractables and leachables: Our scientists perform extractables and leachables testing based on regionally specific guidelines (EU, US, China), nationally and internationally recognized standards (USP, ISO), GMP, PQRI recommendations, USP requirements (chapters <665>, <1663>, &l...
show all 99 other products

Intertek Analytical Services resources (2)

  • Boosting in Vitro Testing for Nasal Drug Products

    News Boosting in Vitro Testing for Nasal Drug Products

    In Vitro Test Methods for Nasal Drug Products VIDEO: Learn how our Alberta Idealised Nasal Inlet (AINI) capability can deliver enhanced IVBE studies for generics and support the development of novel intranasal products targeting specific nasal regions 
    14 Sep 2022
  • Brochure - Pharmaceutical Services

    Brochure Brochure - Pharmaceutical Services

    Covering our full breadth of contract laboratory services, auditing and regulatory consultancy expertise, this brochures provides a summary of our global capabilities.
    Visit www.intertek.com/pharmaceutical for more information.