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Pharmaceutical
Services

Helping Deliver Life-Enhancing Products to Market 

As experts in analytical testing, device optimization, and inhalation science, we believe device and formulation innovation can enhance the delivery and efficacy of drugs to improve patient care. 

scientist wearing blue gloves and safety goggles working with test tubes
Broughton scientist wearing lab coat working at a computer

Receive Expert Support at all Stages of your Product Lifecycle

We support pharmaceutical companies with product development and regulatory compliance. With many years of pharmaceutical laboratory services experience and a team of scientific regulatory experts, we can support your pharmaceutical product development project with scientific strategy and analytical testing, risk assessment and toxicological advice, regulatory submission support, and post market compliance. We have a particular interest and experience in novel inhalation and smart delivery systems.

Compliant Testing Facilities

Our in-house testing and compliance laboratories are based in the United Kingdom and comply with UK Good Manufacturing Practice (GMP) and U.S. Current Good Manufacturing Practices (cGMP) standards and are accredited by the United Kingdom Accreditation Service (UKAS) to ISO 17025 Laboratory Accreditation.

They are regularly inspected by the Medicines and Healthcare products Regulatory Agency (MHRA), the U.S. Food and Drug Administration (FDA), and the United Kingdom Accreditation Service (UKAS) to ISO 17025 General requirements for the competence of testing and calibration laboratories.

Modern research laboratory with computer, microscope and glassware

Our Services

Pharma

With over 15 years of pharmaceutical testing experience and a world-leading team of scientific and regulatory consultants, we bring a wealth of knowledge and expertise to your project. We offer support both as a wholly outsourced unit or as an ongoing extension of your in-house team.

Pharma

Covering different stages of the pharmaceutical product lifecycle, we ensure you receive the data and insight necessary to inform go/no-go decisions at every stage of your project, reducing risk, increasing efficiency, and maximizing your success.

Analytical Testing  

We offer a range of pharmaceutical testing services from our  GMP laboratory facility. Our scientific experts help interpret test data to ensure you have the insight necessary to make informed decisions about the next stage of your product development project, regulatory submission, or post market compliance requirements. 

We ensure ongoing communication is proactive, timely, and from a subject matter expert that understands your project. Communication is vital to excellent customer service, and we put it at the heart of building a one-team mindset with our clients.

 

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scientist-with-test-tubes
Libby Clarke Broughton Group Consultant

Scientific and Regulatory Consultancy

Bringing years of in-house and consultancy experience from a wide range of pharmaceutical areas, our scientific and regulatory experts will bring additional insight and understanding to your pharmaceutical project. Whether you are looking for a single subject matter expert to augment an in-house team or a bespoke cross-functional team to manage an entire project, we have the breadth of consultant expertise to help you succeed.

With a dedicated Technical Project Lead to ensure the efficient running of your project, you will have access to the right expertise at each stage of your project.  You will also benefit from smooth transitions between the different phases of the development lifecycle and an integrated, collaborative approach across scientific disciplines.

 

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Pharmaceutical Regulation

With extensive experience helping clients complete regulatory dossiers for global regulatory bodies, we offer expert guidance and tailor-made scientific strategies supported by regulatory insight and troubleshooting across your pharmaceutical project. We can help you navigate the different stages of a regulatory application, from product development to regulatory submission and post market compliance.

We frequently collaborate and work with the following regulatory bodies:

  • MHRA
  • FDA
  • European Medicines Agency
Generic medicinal tablets and tablet bottles

Pharmaceutical Services Resources

Learn more about how we can help bring your pharmaceutical product to market through high-quality analytical testing integrated with expertise in scientific strategy and an understanding of global regulatory pathways.

A-Guide-To-Pharmaceutical-Marketing-Authorization-in-the-UK

A Guide To Pharmaceutical Marketing Authorization in the UK

The MHRA is now a stand-alone body issuing national authorizations only. This infographic outlines the routes to a Pharmaceutical Marketing Authorization in the UK.

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Pharma-Inhalation-Services

Pharma Inhalation Services

Developing and commercializing new inhaled drug products, requires huge energy and deep scientific understanding. This level of resource and subject matter expertise can be difficult to maintain inside your business, and that is where we can help.

Click to download

Pharmaceutical-Services---Extractables-and-Leachables

Pharmaceutical Services - Extractables and Leachables

The evaluation of extractables and leachables (E&L) is an essential component of the pharmaceutical development process.

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Speak to an Expert 

Arrange a meeting with a scientific or regulatory expert to discuss your project and learn how we can help accelerate your product to market to maximize your success.



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Pharmaceutical Industry Insight and Expert Opinion

Learn more about our activities and gain insight from our scientific and regulatory experts

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2 minute read

The recently concluded Drug Delivery to the Lungs (DDL) conference in 2023 was more than just an annual gathering of professionals in the field—it ....