Our Services

Our regulatory consultants can advise your organisation on the drug development spectrum and optimum regulatory strategy.

It is imperative for your target labelling, any potential orphan drug applications and paediatric investigation plans to be fully evaluated for any possible impact on the environment via an environmental risk assessment and we can help you carry this out well in advance of your marketing authorisation application with the help of our specialists with the knowledge and experience to guide you along the way.

We have experience of regulatory affairs in the field of Pharma, Biotech, Medical Devices and Cosmetics.

We have also recently helped many companies legally set up CBD oil and product businesses along with e-Cigerrettes. Please visit the CBD/E-Cigs tab for more information on those services.

Our aim is to be your truly “one stop” regulatory solution provider and our services include but are not limited to:

Our Services

Strategic and Regulatory Consulting

Ensuring optimum advice during all stages of regulatory development.

MAA Lifecycle maintenance

Management of National, Mutual Recognition, Decentralised, and Centralised Procedures from preparation of initial MA applications through to full post-approval support and variation, renewal applications.

Outsourcing and Interim Management

Our outsourcing services offer your organisation the prospect to outsource entire regulatory functions or specific project work to our highly skilled consultants. We have the capability to support your organisation for any long or short term projects or gaps in employment such as illnesses or maternity leave cover – work can be carried out at our offices or onsite as per your requirements. We are also preferred suppliers for some of the biggest pharma company’s in the UK.

CMC regulatory affairs

preparation of Module 3 dossiers, IMPDs and also CPPs

Clinical Trial Applications

Submission preparation, handling the submission process for Health Authorities and Ethics Committees, Substantial and Non-Substantial amendments

Communication with regulatory authorities

On behalf of your company

Preparation of country specific submission documents

Such as Module 1-5 dossiers

Labelling, SmPCs, / Medical writing services

User Testing

Patient readability testing for patient information leaflets and bridging strategies. We can also produce, redesign, refine and align PIS and ICF for clinical trials.

eCTD Publishing

We have in house capabilities to support your regulatory submissions

Scientific Advice

Assist in identifying the key challenges and specific technical questions and help you discuss these with regulatory authorities.

Regulatory Training

Our highly skilled teams can present in house or external training at conferences on a wide range of regulatory activities.

SOP Writing

We have experience of writing SOPs for clients across a number of regulatory and quality area.

Merger / Divestment and Acquisition support

We have extensive experience and have worked on some of the industries biggest mergers and divestment projects ensuring a streamlined strategy and support right up until “Day 0” and beyond.

Due Diligence and Gap Analysis

We conduct regulatory due diligence to help you understand potential risks and to help mitigate your exposure prior to agreeing a deal with targeted firms.

BREXIT Support

We have extensive experience is preparing companies for BREXIT for both a deal and no deal scenario.

Marketing authorisation support for sponsors outside EU

We have the capability to represent your company across the EU and are fully equipped to act as your satellite office in the EU region.

QP services

We have a panel of certified QPs available at short notice for short and long term assignments.

Interaction with regulatory agencies world-wide

We have extensive experience of working with regulatory agencies across the globe.

Get in touch!

We’re proud to offer a range of solutions for regulatory affairs. If you’d like to find out more, please get in touch!