Drug Stability Testing and ICH Storage Outsourcing
Product Description
Intertek Analytical Services
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GB
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2015On CPHI since
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4Certificates
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1000 - 4999Employees
Company types
Primary activities
Categories
Specifications
Intertek Analytical Services
-
GB
-
2015On CPHI since
-
4Certificates
-
1000 - 4999Employees
Company types
Primary activities
More Products from Intertek Analytical Services (29)
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Product Biologic Quality Control and Release Testing
We deliver responsive QC analysis for complex biologic products from our cGMP laboratories. Our scientists develop and validate methods or perform technology transfer of a sponsor's method for a wide range of analytical methods required for batch release testing. We also routinely carry out testing to Phar... -
Product Cell-based Neutralization Assays
Experienced cell-based neutralizing antibody assay capabilities. Our experts, at our GLP/GCP compliant laboratory, evaluate each therapeutic, conduct tailored assay development and ensure that each assay is optimized to suitably determine the presence of NAb with maximum possible level of drug toleran... -
Product Vaccine Characterization and Bioanalytical Support
Our vaccines development experts provide a suite of services supporting the analysis and 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, lipi... -
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 ... -
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... -
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... -
Product GMP and CMC Laboratory Services
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 s... -
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... -
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... -
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... -
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... -
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...
Intertek Analytical Services resources (15)
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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 -
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. -
Sponsored Content Intertek’s Pharmaceutical Audit Services Team celebrates 15 years of excellence
Celebrating 15 years of delivering flexible auditing solutions for the global healthcare, pharmaceutical, and cosmetics sectors, our Pharmaceutical Audit Services Team have continually innovated to build a set of relevant auditing services to help clients meet the evolving challenges of driving quality and visibility across complex global supply chains.
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Brochure Brochure - Inhalation Drug Product Development Expertise
Our inhalation product experts have been working in the inhaled and nasal fields for nearly 30 years and possess the necessary experience to help design, implement and support full development, stability and testing services which are designed to provide the right information at the right time. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards. -
News The Vaccine and Therapeutics Development Digital Resources Have Been Released
Our library of digital resources is available to enhance your knowledge-base and educate you along every step of the drug development process. Keep up-to-date with industry hot topics and the latest research developed by our thought-leaders. -
Brochure Poster - Top 5 Considerations for Outsourcing Stability Storage
WHAT SHOULD YOU EXPECT FROM YOUR OUTSOURCING PARTNER? WHAT DOES YOUR OUTSOURCING PARTNER NEED FROM YOU?
Intertek Melbourn have provided GMP stability storage services since 2004. Our Stability team are currently coordinating over 200 stability studies for more than different 30 clients from across all global territories. We offer over 375,000L of capacity over various conditions, including ICH and bespoke conditions. -
News Expansion in characterisation and development support for mRNA vaccines and therapeutics.
Intertek Pharmaceutical Services has expanded laboratories services supporting mRNA vaccine and therapeutic products. At our GLP / GCP / GMP laboratories, scientists can test mRNA drug substance or drug products to help you confidently assess batch to batch manufacture and process repeatability as well as the quality of mRNA. Additionally, our experts provide mRNA specific methods including integrity, potency, capping efficiency, residual DNA template, residual dsRNA and delivery system testing. -
Brochure Poster - Flexible Outsourcing Solutions, Laboratory Services
Our team support you across your development and production lifecycle including cGMP and GLP/GCP compliant characterization, stability, release testing and bioanalysis. You will need a strategic partner who invests in scientific and technical excellence to help you to develop and launch a pipeline of new products that meet the needs of patients, buyers and consumers. -
News Intertek expands pharmaceutical services to expedite clients’ biologics and gene therapy development
A new facility, currently being commissioned, to bring increased capacity for contract lab services for clients developing biologics and gene therapies. Expanded footprint and capabilities include temperature-controlled laboratories, leading-edge analytical technologies with recruitment of over 60 additional scientists, statisticians and regulatory project managers. -
Brochure Brochure - Oligonucleotide Analytical Development Services
Our scientists have supported oligo medicine drug development since the inception of this class of therapeutics. Through our dedicated suite of characterisation techniques we are focused on helping you to meet industry requirements for regulatory compliant (GMP or GLP) characterisation and quality control for oligonucleotide based drugs. Bringing quality and safety to life, our Total Quality Assurance expertise is delivered consistently to help you ensure you meet and exceed your quality, safety and efficacy requirements. -
Brochure Brochure - Biopharmaceutical Analytical Development Support
We have nearly 30 years of experience in biopharmaceutical development support across a wide range of product types, including proteins, monoclonal antibodies, vaccines, PEGylated proteins, antibody drug conjugates, peptides, cytokines (e.g., interferons), oligonucleotides, glycoproteins, and biosimilars. With broad capabilities in Europe and North America, our Total Quality Assurance expertise is delivered consistently to help you meet and exceed your quality, safety, and efficacy requirements. Intertek's experts provide strong scientific and technical leadership, coupled with project management and regulatory support, to drive your development and manufacturing programs forward. -
Brochure Brochure - Global Stability Storage Facilities and Services
Global Stability Storage Facilities and Services. -
Brochure Brochure - Bioanalysis Services
Bioanalysis plays a critical role in the assessment of drug safety and efficacy. We understand that each project presents its unique challenges, and by applying our nearly 30 years of experience in conducting regulatory bioanalytical studies, our teams work closely with you to ensure that the best possible solutions are delivered, optimizing value for your programs. With Intertek as your partner, you have access to the scientific and regulatory knowledge of our bioanalytical experts, so that you can leverage the insight we bring to accelerate your drug development. -
Brochure Brochure - mRNA Vaccine & Therapeutic Products Analytical Development Services
By integrating advanced analytical technology with a heritage supporting pharmaceutical product development, our experts offer Total Quality Assurance to help you ensure the safety, efficacy, and quality of your mRNA therapy. -
Technical Data Factsheet - ATMP Analytical Development Services
The complexity of Advanced Therapy Medicinal Products (ATMPs) and their mode of action, present many challenges to development. Our experts provide analytical development and routine testing to help you meet regulatory expectations for safety and efficacy.
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