GMP and CMC Pharmaceutical Laboratory Services
Chemistry, manufacturing and controls (CMC) and GMP contract pharmaceutical laboratory services and outsourcing support to accelerate and optimise your drug development programs
Outsourcing your GMP and CMC pharmaceutical laboratory services needs can help you to optimise and accelerate your drug development programs. CMC contract lab services, delivered from expert analytical and formulation scientists, can also help you to identify sources of risk early in development and provide sufficient information to assure the identity, quality, purity, strength, and stability of the drug product to meet regulatory requirements and specifications. When you prepare for an important submission, GMP analytical packages must demonstrate consistency and reliability of the manufacturing process which can involve specialist analytical expertise. To achieve the desired characteristics for the dosage form within project timelines, you will need formulation development knowledge, followed by clinical trial supply manufacturing that is both fully GMP compliant and monitors all areas of risk to ensure product quality.
Regulatory–driven CMC laboratory services
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.
Integrated formulation, GMP analysis and clinical trial supply manufacturing
Our formulation development scientists are experienced across a range of dosage forms including orally inhaled and nasal drug products (OINDP), oral, solid, liquid and transdermal or topical for small molecule and biologics. Strategic integration of formulation development with analytics ensures a detailed understanding of the pharmaceutical materials, their compatibility, physical properties and stability. Our development teams offer cost-effective GMP manufacturing services for clinical trials aligned with IND or Common Technical Document CTD support which includes raw material characterization, sourcing, scale-up and pilot batch manufacturing to ensure product quality.
Pharmaceutical knowledge to accelerate your development
With an experienced eye on the current regulatory guidance, our formulation and analytical scientists work with you to utilize exactly the right approaches and analytical methods to deliver the data you need to take the next step for both small molecule pharmaceuticals or biopharmaceuticals. With over 20 years of experience providing flexible outsourcing solutions for the most innovative pharmaceutical organisations, our Total Quality Assurance expertise can help you to achieve the appropriate quality and regulatory standards at each stage of development.
GMP and CMC Services
GMP analysis for Active Pharmaceutical Ingredients (APIs) and drug productsBiopharmaceutical CMC solutions
Preformulation and physical characterisation
Method development & validation
Stability studies
GMP batch release testing
Extractables and leachables
Pharmaceutical Impurity Testing
RESOURCES:
App Note: Determination of Low/Trace Level Benzene in Pharma Excipients and Finished Products
Webinar: NMR Quantification and Characterization
Webinar: Design of Extractables Leachables Studies
Article: Nitrosamine Impurity Screening in Drugs
Article: Pharma Stability Contingency and Disaster Recovery
Webinar: E/L Studies for Process Materials and Container Closure Systems
Webinar: ID & Quantification of Pharma Impurities
Pharmaceutical Laboratories
Intertek Pharmaceutical Services (Whitehouse, NJ, USA)
Intertek Pharmaceutical Services Manchester (UK)
Intertek Melbourn (UK)
Intertek Switzerland Analytical Laboratory (Basel, Switzerland)
GMP and CMC Laboratory Services, India (Mumbai, India)
Explore Our Pharmaceuticals Services
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COVID-19 VACCINE OR THERAPEUTIC TESTING & DEVELOPMENT SUPPORT
IMMEDIATE QUESTION? Ask our experts now
FACTSHEET: COVID-19 Vaccine or Therapeutic Testing & Development Outsourcing
ARTICLE: Repurposing Vaccines for Intranasal Development
WEBINAR: Quality Control Strategy for Vaccine Development
WEBINAR: Repurposing Drugs for Inhaled Delivery
eBOOK: Contingency Outsourcing Solutions
Pharmaceutical Impurity Analysis Service Update:
Detection and quantification of nitrosamine impurities (NDMA, NDEA, NMBA and NDIPA) using GC-MS and LC-MS methods. Learn more about this service.NEW! Discover our Audit Live Tool for direct access to our scheduled audits
EVENT: 2nd Annual Inhaled and Nasal Biologics/DNA Forum - REGISTRATION IS LIVE
VIDEO:EXTRACTABLES/LEACHABLES LAB TOUR - Request access
WORKSHOP: How to Build an Inhaler (RDD 2023)
PRESENTATION:E&L Strategies (3rd Annual Extractables & Leachables Conference)
TALK: Medical Device Extractables & Leachables Studies
TALK: ID and sensitivity issues during E&L studies
ARTICLE: Glycosylation Analytical Approaches for Antibody Therapeutics
APP NOTE: Rapid Determination of Low/Trace Level Benzene in Pharmaceutical Excipients and Finished Products
ARTICLE: Importance of Aligning a Pharma Audit Scope with the Correct Standard
TALK: mRNA Analytics: Capping Efficiency, Sequencing, Poly-A Tail, dsRNA