Laboratory Services

Laboratory Services

Leading Laboratory Expertise

Our Facilities

Broughton's laboratory services operate out of two facilities in the United Kingdom, easily accessible from Manchester and Leeds Bradford airports. Our facilities are designed and operated to optimize efficiency and comply with industry regulations to ensure that data is delivered on time and to the highest quality standards.

Facility Quality Management System Method Development, Validation and Optimization QC Batch Release Testing Non-Routine Analysis Stability Storage and Analysis HPHC Testing In Vitro Sample Generation
Skipton GMP Certified (MHRA and FDA)
 
 
 
 
 
 
Earby GLP Certified (MHRA) and ISO 17025 Accredited (UKAS)
 
 
 
 
 
 
Dedicated Team of Scientists
A Dedicated Team of Scientists

Whether your product is a pharmaceutical active or drug product, consumer nicotine or cannabinoid based, Broughton has a full range of chemistry and toxicology testing services to accelerate your product to market or ensure ongoing quality commitments are met. Our team is highly skilled in product analysis and characterization, covering many product actives and dosage forms.

Broughton's laboratory services team not only generate the scientific data, but we take the time to understand both the purpose of your studies and the impact of the data. From aiding with study design through to statistical analysis and interpretation of the data, Broughton offers more than a standard contract laboratory service.

Our Services

 

Our established industry experience in providing analytical services means Broughton can support your journey in delivering life-enhancing products to market. These services include:

  • Method Development
  • Method Validation
  • Non-Routine Analysis
  • Product Development Analytical Support
  • Stability Studies
  • Quality Control and Batch Release Testing
Our Services
Method Development
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Flexible Testing Approaches

Method development

We can develop methods according to your needs, from assay and related substances methods for a new product or active to optimizing pre-existing methods to utilize current technologies such as Ultra High Performance Liquid Chromatography (UHPLC). Our service can encompass all aspects of the method, from sample preparation to results generation. We can also assist in rectifying technical issues with existing methods.

Method validation

We conduct stage-specific and fit-for-purpose method validation following ICH guidelines. We offer method validation services for methods developed in-house and at other laboratories.

Non-Routine Analysis

Non-routine analysis can be anything from performing a stability study on a new product to understand shelf life, to urgent testing on a released product to determine if a recall is required. We also support clients with other non-routine requirements, such as cleaning validation, and license variations and updates.

Product Development

We ensure a rapid turnaround of prototype or existing product assessment, ensuring that your development process does not stagnate. Whether it be assessing the uniformity of a formulation or the consistency in dosing of a finished product, providing data as quickly as possible is essential so that any improvements to the process or product design can be made iteratively to improve the product.

Stability Studies
Our stability studies include shelf life and accelerated studies, photostability, extractables and leachables, execution and transit studies. Our team of expert scientists can help you design and execute the following stability studies:
  • Shelf-Life Studies – designed to detect the potential degradation of the product that may result in toxic chemicals over the product's lifespan to keep your customers safe and your brand protected.
  • Accelerated Studies – to rapidly determine the stability-indicating analytes to build a projection of a product's potential stability over its desired shelf life. Early knowledge of stability behavior can be critical in saving cost and time during pre-market regulatory projects.
  • Photostability – to assess the effect of light on the product and the product container closure system to help maintain protective measures against photodegradation for product safety.
  • Extractables and Leachables – to investigate, identify, and monitor the wide variety of compounds that may be present in either the delivery device or the formulation; and which may therefore present an exposure risk to the end-user of the product.
  • Stability Storage - We are able to provide stability storage in purpose-built walk-in climatic chambers located in a secure Good Manufacturing Practice (GMP) environment. The chambers are controlled via a fully validated data management system in accordance with GMP requirements and ICH harmonized guidelines for stability testing of new drug products and substances. Each chamber is temperature and humidity controlled to +/-2°C and +/-5%RH of its target conditions, with 24hr monitoring of chamber conditions and immediate notification of deviations.
Stability Studies
Quality Control and Batch Release Testing
Quality Control and Batch Release Testing

Broughton’s proven history as a trusted provider of quality control and batch release testing for regulated products, such as veterinary medicines, pharmaceutical and consumer nicotine makes us an ideal partner for your testing, inspection, and quality control testing needs.

We pride ourselves in providing rapid turnarounds to fit to your commercial timeline, understanding that ensuring product compliance to specification throughout its manufacturing and release lifecycle is critical in delivering safe life-enhancing products to patients.

Our proactive approach enables quick identification of atypical results, allowing you to take appropriate action to ensure safe and effective products are delivered to the market.

HPHC Testing

Harmful and potentially harmful constituents (HPHCs) testing for next generation nicotine products (NGPs), ensuring methods are suitably sensitive to meet global regulatory requirements.

The determination of HPHCs in Electronic Nicotine Delivery Systems (ENDS) products are a critical factor to assess the potential health benefits of NGPs relative to the known risks of combustible cigarettes, and are a mandatory requirement of regulatory approval such as U.S. PMTA (Premarket Tobacco Product Application) submissions.

Broughton are well established in providing HPHC analytical testing for NGPs. We have developed and validated highly sensitive analytical methods that operate within a lean laboratory environment to deliver high-quality HPHC data within a rapid turnaround time specific to the NGP industry.

Broughton offers the full suite of HPHC testing as specified in international guidelines and directives. ln addition, other constituents classified as respiratory irritants are analyzed to comply with US PMTA requirements.

Document management is in full compliance with United Kingdom Accreditation Service (UKAS) ISO/IEC 17025:2017, FDA 21 CFR Part 820 and International Conference on Harmonization (ICH) Q2R2 requirements and records are maintained within a Tobacco Product Master File (TPMF).

Our scientists are highly skilled in developing and validating analytical methods to meet global regulatory requirements. We have extensive experience working across a wide range of ENDS products for the determination of the core HPHCs listed by FDA and can rapidly develop new methods to assess HPHCs that may be more unique to individual product designs.

HPHC Testing
HPHC Testing
Experimental Toxicology Services
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Experimental Toxicology Services

With a wealth of experience across multiple industries, Broughton's toxicology team are expertly placed to help you with the nonclinical development of your product, or medicinal or consumer product. Our toxicologists have hands on experience of product development, nonclinical study design and conduct, and toxicological safety and risk assessments. Our experimental toxicology services include:

  • Management of your nonclinical package according to ICH guidance, with modifications relevant to your needs. Our experts can provide guidance in the identification of relevant nonclinical data requirements, experimental study design, study commissioning and monitoring, evaluation and interpretation of study data and ongoing nonclinical development strategies. 
  • Liaison with CROs. Our services include identification of suitable CRO partners, full study monitoring and on-site inspections and GLP audits.
  • Submission-ready compilation of your nonclinical data package. Whatever the regulatory framework you are working towards, we can prepare your nonclinical data submission and provide pre- and post-submission toxicology support.

 

Industries

Building on years of experience in the pharmaceutical and alternative nicotine delivery spaces.

Broughton offers a fully integrated scientific and regulatory consultancy, combined with comprehensive laboratory services, across the nicotine, cannabinoids, and pharmaceuticals industries.

Contact us

From basic questions to complex compliance inquiries, we're here to help! Contact us today.