PHARMACEUTICAL TESTING IN THE UK

>> Services >> PHARMACEUTICAL TESTING IN THE UK.

The company leads pharmaceutical analysis through innovative testing solutions that protect public health while ensuring treatment efficacy. The combination of precision technology and deep industry expertise at our facilities allows us to validate pharmaceutical products and medical devices along with packaging systems to match the most demanding international quality criteria.

The Critical Role of Pharmaceutical Testing in the UK.

The pharmaceutical safety and efficacy process relies on intensive testing methods as its fundamental basis in present-day healthcare systems. Modern pharmaceutical business operations must navigate through multiple obstacles related to product quality control, including mounting regulatory supervision and manufacturing system advancements. Our extensive testing solutions face down the specific challenges through scientific verification methods that ensure pharmaceutical product quality throughout development.

We deliver vital assurance through multiple critical pathways. Our sophisticated protocols encompass comprehensive safety validation to protect patient well-being, utilizing advanced analytical methods to detect even trace contaminants and impurities. The laboratory performs testing to verify therapeutic efficiency through exact measurements of therapeutic availability combined with dissolution speed analysis and active chemical ingredient maintenance. Our strategic regulatory compliance services enable fast market entry yet achieve the absolute best quality standards. The authentication methods we implement fight counterfeit pharmaceuticals, and our stability assessment techniques verify product storage needs by subjecting products to environmental tests. A synergy exists between these services, which protects the therapeutic properties of your products from start to finish.

European and International Standards Excellence

At our facilities we follow all requirements of United Kingdom's preeminent regulatory frameworks that prioritize the Medicines and Healthcare products Regulatory Agency (MHRA). Our testing process conforms to the GLP Monitoring Program and GMP guidelines of the MHRA for meeting the UK market authorization criteria. The Human Medicines Regulations 2012 together with the Medicines Act 1968 enable our facilities to offer complete adherence to all UK-specific requirements for pharmaceuticals and medical devices and combination products.

Our organization upholds strict adherence to the European Medicines Agency (EMA) Clinical Trials Regulation (EU) No 536/2014 international standards while implementing UK Clinical Trials Framework procedures to meet British requirements post-Brexit. Our testing methods apply the guidelines set by the International Council for Harmonization from Q1 to Q12 with emphasis on Q2(R2) for analytical method validation and Q6A for specifications assessment of new drug chemicals and medications. Our testing and calibration laboratory operates under ISO/IEC 17025:2017 accreditation to showcase our dedication to producing technical skilled results.

Beyond these foundational standards, we incorporate additional specialized frameworks including the European Directorate for the Quality of Medicines (EDQM) standards and the British Pharmacopoeia (BP) specifications. The testing protocols we use conform to the UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) together with the In Vitro Diagnostic Medical Devices Regulations 2000 (SI 2000 No 1315). Atlaz Medical applies specialized MHRA standards for product testing procedures and GMP regulation when working with advanced therapy medicinal products (ATMPs). We also maintain compliance with the Yellow Card scheme for pharmacovigilance and adverse event reporting, ensuring comprehensive safety monitoring throughout the product lifecycle.

Key Sectors of Excellence

Our pharmaceutical testing in the UK expertise spans the complete spectrum of healthcare products, beginning with our comprehensive medicines and drugs division. We demonstrate expertise in analyzing oral medications and complex injectable therapeutics through advanced methodologies used to prove dissolution rate assessments and potency assessment along with content uniformity verification. The company performs extensive sterility tests for every product while focusing extra attention on endotoxin measurements and microbiological safety tests.

Our testing capabilities operate around the packaging materials sector. The testing facility evaluates basic packaging elements with precise examinations that measure blister packing moisture protection and plastic-object chemical response and glass ampoule structural stability. The testing methodology addresses innovative sustainable packaging solutions to ensure their compliance with environmental standards as well as pharmaceutical protection benchmarks.

Our organization offers specialized testing services that evaluates advanced drug delivery technologies in the fast-growing field of pharmaceutical products. Our expertise encompasses the validation of pre-filled syringes, transdermal delivery systems, and advanced inhalation devices. Each system undergoes complete evaluation for its dose precision and drug delivery profile testing and stability assessment under different environmental conditions.

The medical devices sector demands exceptional precision in testing, particularly for products that interface directly with patients. Our laboratories conduct thorough biocompatibility studies, sterility validations, and functionality assessments for devices ranging from diagnostic equipment to drug-delivery mechanisms. We maintain specialized testing protocols for combination products that merge pharmaceutical and device elements.

Our biologics and vaccines segment maintains testing facilities having ultra-low temperature storage added to constant monitoring systems. Specialized testing protocols from our company specifically handle biological products by conducting stability examinations of proteins alongside potency measurements as well as evaluating cold chain system integrity. We utilize advanced analytical techniques to check product quality and safety of both emerging cellular and gene therapy products.

Key Testing Criteria and Methodological Strengths

The pharmaceutical testing in the UK process at our facility bases its operations on three fundamental elements which include analytical precision together with regulatory compliance alongside scientific innovation. The testing process needs a detailed assessment of product specifications at its start to develop valid and repeatable testing results. The pharmaceutical analysis features state-of-the-art techniques including high-performance liquid chromatography, mass spectrometry and sophisticated spectroscopy approaches for comprehensive chemical identification.

The fundamental structure of testing methodology relies on quality assurance practices. The testing methods follow validation protocols according to international standards and focus specifically on developing high precision alongside accuracy and specificty. The stability testing programs use accelerated and real-time studies which provide reliable data for determining shelf life and storage requirements. Environmental chambers simulate distinct climate patterns that help manufacturers confirm products stay unchanged after storage and transport through different environmental conditions.

The safety assessment component of our testing encompasses comprehensive evaluations for impurities, degradation products, and potential contaminants. The labs perform highly sensitive examination methods to identify and measure small amounts of heavy metals alongside organic contaminants and microorganisms. Our testing of pharmaceutical packaging materials involves thorough extractables and leachable studies which identifies the interactions between drug products and their container closure system components.

Our Core Strengths

Testing excellence at our organization depends on a team consisting of specialized scientists along with regulatory experts. Researchers with extensive pharmaceutical analysis experience alongside expertise in modern regulatory standards, analytical methods and remaining updated on latest requirements operate within our team. Our scientific team often joins international standard development bodies to maintain their position as leaders in pharmaceutical testing practice.

Our laboratory infrastructure represents significant investment in advanced analytical technology. We maintain dedicated facilities for specific testing categories, including clean rooms for sterility testing, environmental chambers for stability studies, and specialized units for biological product analysis. This segregation ensures optimal testing conditions while preventing cross-contamination risks.
The laboratory stands apart because it delivers fast results without ever reducing test accuracy. The efficient operational flow of our laboratory combined with our advanced data management systems allows efficient processing of samples and data. The efficient documentation procedures at our facility produce extensive analytical reports for clients who use them to meet regulatory requirements.
Innovation drives our approach to pharmaceutical testing in the UK challenges. We continuously evaluate and implement new analytical technologies and testing methodologies, ensuring we can address emerging pharmaceutical products and novel delivery systems. Thanks to our forward-looking method and regulatory expertise together with technical capacity we become a reliable quality assurance and pharmaceutical product development partner.

Pharmaceutical Products Testing

1. Medicines and Drugs

Our testing laboratory provides appropriate analysis for diverse medicinal products to guarantee correct formulation and suitable pharmacological standards. Our services include testing for,

  • Tablets and Capsules: The manufacturing process includes tests for content uniformity, dissolution and disintegration combined with stability checks for optimal performance.
  • Injectable Drugs (vials, ampoules): Sterility testing, endotoxin testing, and stability studies to verify the safety and efficacy of injectables.
  • Liquid Syrups: Testing for viscosity, pH levels, stability, and microbiological contamination.
  • Ointments and Creams: Multiple assessments check the consistency, spreadability, stability and microbial properties for assuring product integrity and skin compatibility.
  • Inhalers and Nebulizers: Performance testing for dose uniformity, aerodynamic properties, and product stability.
  • Suppositories and Pessaries: The clinical testing evaluates dissolution speed and drug release patterns while checking for stability implications on medication delivery.

2. Packaging Materials

We test various pharmaceutical packaging materials to ensure they protect the integrity of the drug product and meet regulatory standards. Our testing services for packaging include,

  • Blister Packs for Tablets and Capsules: The research assessed the sealing strength combined with moisture resistance and barrier property performance.
  • Plastic Bottles for Syrups and Suspensions: Leak testing, stability assessments, and compatibility with the drug product.
  • Ampoules and Vials (Glass and Plastic): Verified strength, sterilization compatibility, and formulation suitability of glass and plastic ampoules and vials.
  • IV Bags and Fluid Containers: Evaluation for container integrity, material compatibility, and performance under different conditions.
  • Sealing Films and Wraps: Testing for sealing strength, moisture permeability, and protective qualities.
  • Laminated Pouches for Powders and Granules: Tested for moisture, oxygen, and light barriers.
  • Child-Resistant Caps and Closures: Safety testing of child-resistant caps and closures assures regulatory compliance.

3. Drug Delivery Systems

We specialize in testing advanced drug delivery technologies, ensuring they function as intended and provide the desired therapeutic outcomes. Our services include testing for:

  • Pre-filled Syringes: The accuracy of pre-filled syringes undergoes testing alongside determination of sterilization methods and drug stability evaluations.
  • Auto-injectors: Performance evaluations for ease of use, reliability, and dosing accuracy.
  • Transdermal Patches: Assessments for drug release rates, adhesive properties, and skin irritation potential.
  • Nasal Sprays and Applicators: The researcher tests formulations for their dose consistency as well as their spray distribution along with stability duration.
  • Drug-eluting Stents: Evaluation of drug release profiles, stability, and biocompatibility.

4. Medical Devices

Our testing services also extend to medical devices, ensuring they are safe, effective, and compliant with health regulations. We provide testing for:

  • Blood Collection Tubes: Evaluation of material compatibility, sterility, and functionality.
  • Catheters and IV Lines: Strengthening tests parallel flexibility tests along with assessments of material compatibility with living tissues and sterilization method examinations.
  • Infusion Pumps and Parts: Performance testing to ensure precise fluid delivery, durability, and patient safety.
  • Diagnostic Kits (e.g., COVID-19 test kits): Testing procedures for accuracy as well as sensitivity, specificity, and stability tests validate test performance.
  • Drug Testing Strips: Evaluation for reliability, sensitivity, and ease of use.

5. Biologics and Vaccines

We provide comprehensive testing services for biologics and vaccines, including stability and safety assessments that ensure product quality. Our services include,

  • Vaccine Vials and Packaging: Stability testing, sterility checks, and container compatibility evaluations.
  • Biopharmaceutical Injectables: Evaluation of potency along with purity, safety testing verifies the effectiveness of biopharmaceutical products.
  • Lyophilized (Freeze-dried) Biologics: Evaluation of reconstitution times, stability, and potency post-reconstitution.

6. Nutraceuticals and Supplements

The company provides testing services to verify multiple nutraceuticals and dietary supplements for product quality alongside consistency and safety. Our testing includes

  • Vitamin Tablets and Capsules: Assays for active ingredient content, dissolution rates, and stability.
  • Nutritional Powders (e.g., protein shakes, infant formula): Testing for nutrient content, mixability, and microbiological safety.
  • Soft Gels and Chewable Gummies: Evaluations for ingredient potency, uniformity, and stability.
  • Liquid Nutritional Supplements: The active ingredient concentration and microbiological safety along with stability need to be evaluated.

7. Ancillary Products

Our testing process for ancillary products evaluates their safety level as well as their reliability and ease-of-use for pharmaceutical adjuncts. We provide testing services for,

  • Pill Organizers: Ensuring that they are durable, easy to use, and comply with safety standards.
  • Measuring Spoons and Cups: Organizations need to evaluate accuracy dimensions alongside material compatibility for pharmaceutical items.
  • Droppers and Dosing Syringes: Testing for precision, durability, and ease of use for correct medication administration.
  • Medicine Dispensers: Performance and safety evaluations to ensure accurate dosage delivery.

8. Method Development & Validation

METS UK is the listed release lab in numerous agency filings. We are routinely audited by our clients, are registered with a variety of regulatory agencies (FDA, DEA, Health Canada) and are highly experienced in solid mixture analysis. Our services cover,

  • Analytical Method Development
    • Dissolution Methods
    • Spectroscopic Assays (Raman, FTIR, UV, NMR)
    • X-ray Powder Diffraction Analysis (Quant, Limit, ID)
    • Chromatographic Assays (HPLC, LC-MS, GC-MS)
    • Particle Size Assays (Wet & Dry)
    • Karl Fischer
    • Optical Rotation
  • Method Validation
  • Technology Transfer
  • Detection Limit Testing
  • Linearity Testing
  • Precision Testing
  • Repeatability Testing
  • Accuracy Testing
  • Quantitation Limit Testing
  • Contaminant Analysis, Patient Complaint Samples
    • Foreign material identification
    • Extractables/leachable identification
    • Root cause analysis
  • Compendial Testing
    • USP/EP/JP/BP/PhEur Monograph Testing
    • Raw material (API/Excipient) identification
    • CoA issuance
    • Limit Test for Impurities
    • Assays for Drug Substances and Formulations
    • System Suitability Testing
  • cGMP Batch Release Testing
    • CoA issuance
    • Drug Substances
    • Drug Products
    • Tablets and Capsules
    • Excipients
    • Medical Device Testing
  • Reference standard generation and qualification
  • Analyze completed products and bulk lots to ensure purity, concentration, uniformity, and identification

Partner with Excellence

Your pharmaceutical products need testing excellence which requires experience and innovation with absolute quality standards. Our testing expertise in worldwide pharmaceuticals continues successfully across multiple product groups and markets during decades of successful testing operations. The fully accredited testing facilities under our operation follow strict quality management systems to provide you with consistent reliable results.

Choose us as your partner in pharmaceutical testing in the UK, and experience the confidence that comes from working with a leader in pharmaceutical analysis. Together, we'll ensure your products meet the highest standards of safety, efficacy, and quality.

Need specialized chemical testing? Share your project details with us, and we'll provide a personalized quote to meet your requirements