Trusted Pharmaceutical Testing Services
Oxford Analytical Services provides expert pharmaceutical testing services to ensure that drug formulations, excipients and active pharmaceutical ingredients (APIs) meet strict quality, safety and compliance standards. Our GLP compliant laboratory delivers precise, reliable and regulatory approved pharmaceutical testing, helping manufacturers navigate the complexities of product development, impurity profiling and ICH stability studies.
Our team of highly experienced chemists and regulatory specialists collaborates with R&D teams, quality assurance managers and regulatory affairs professionals, offering analytical insights that support product innovation, compliance and market approval.
Pharmaceutical Industry Challenges We Solve
Bringing pharmaceutical products to market requires rigorous pharmaceutical testing, regulatory validation and scientific precision. We help solve:
- Regulatory Compliance & Product Registration: Ensuring adherence to ICH stability guidelines, EMA, FDA and MHRA requirements
- API & Excipients Testing: Verifying the purity, potency and composition of raw materials and active ingredients
- Impurity & Contaminant Profiling: Identifying residual solvents, heavy metals, degradation products and genotoxic impurities
- Shelf Life & ICH Stability Studies: Conducting long term and accelerated stability testing to determine product performance
- Dissolution & Bioavailability Testing: Assessing drug release, solubility and absorption rates for formulation optimisation
Our scientific expertise and regulatory knowledge ensure that your pharmaceutical products meet the highest standards of quality, safety and compliance.
Why Partner with Oxford Analytical Services?
Regulatory Focused Pharmaceutical Testing Services
Our GLP compliant analyses support global regulatory submissions, ensuring compliance with:
- ICH Stability Guidelines (Q1A-Q1F) for drug stability and shelf life testing
- European Medicines Agency (EMA) Regulations
- Food and Drug Administration (FDA) Requirements
- MHRA (UK) Compliance for Good Manufacturing Practice (GMP) Standards
Comprehensive Pharmaceutical Testing Services
We offer a full suite of pharmaceutical testing capabilities, including:
- API characterisation & raw material testing
- Impurity profiling & heavy metal detection
- Shelf life testing & ICH stability studies
- Dissolution, solubility & bioavailability assessments
Expert Support from Development to Market Approval
From early stage drug formulation to post market ICH stability studies, we provide tailored support to ensure your pharmaceutical products meet global regulatory and safety standards.
Cutting-Edge Techniques for Pharmaceutical Testing
We utilise HPLC, GC-MS, LC-MS/MS, ICP-MS, FTIR and other advanced techniques to deliver highly accurate and reproducible data.
Partner with Oxford Analytical Services for Pharmaceutical Testing
- Industry Specific Expertise – Supporting pharmaceutical manufacturers, contract research organisations (CROs) and regulatory consultants
- State-of-the-Art Techniques – Delivering comprehensive pharmaceutical testing services for compliance, safety and product efficacy
- Customer Focused Approach – Providing tailored solutions to meet your unique analytical and regulatory challenges
Our services include:
Assesses product consistency across batches, ensuring compliance with regulatory standards. Determines technical equivalence by comparing composition, impurities and physical properties to reference materials. Learn more.
Provides expert guidance on analytical strategies, regulatory compliance, method selection and problem solving. Supports research, product development and troubleshooting for various industries. Learn more.
Determines the elemental composition of materials, detecting trace metals and other elements using techniques like ICP-MS and ICP-OES. Essential for regulatory testing and material characterisation. Learn more.
Identifies and quantifies impurities in raw materials, intermediates and final products. Ensures compliance with safety standards and supports formulation optimisation. Learn more.
Confirms the accuracy, reliability and reproducibility of analytical methods through independent verification, ensuring compliance with regulatory requirements. Learn more.
Diagnoses unknown contaminants, product failures, or unexpected variations using a range of analytical techniques. Supports root cause analysis and corrective actions. Learn more.
Designs and optimises robust analytical methods tailored to specific applications. Validates methods to ensure accuracy, precision, specificity and regulatory compliance. Learn more.
Evaluates key physical and chemical properties, such as solubility, stability, pH, viscosity and refractive index, supporting material characterisation and regulatory submissions. Learn more.
Characterises polymer composition, molecular weight, degradation and thermal properties. Supports material selection, quality control and failure investigations. Learn more.
Determines the chemical makeup of products, ensuring formulations meet regulatory and quality requirements. Useful for verifying ingredient levels and detecting contaminants. Learn more.
Provides regular testing to verify product consistency, purity and compliance with specifications. Supports manufacturing and regulatory compliance. Learn more.
Uses innovative and targeted approaches to detect unexpected compounds, emerging contaminants, or novel substances, supporting research and development. Learn more.
Evaluates product stability under various conditions to determine shelf life, degradation pathways and compliance with regulatory guidelines. Learn more.
Identifies unknown compounds using advanced spectroscopic and chromatographic techniques, ensuring proper classification, safety assessment and regulatory compliance. Learn more.