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.
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
Clinical Trial Applications
Submission preparation, handling the submission process for Health Authorities and Ethics Committees, Substantial and Non-Substantial amendments
Labelling, SmPCs / Medical writing services
We provide reliable labeling, SmPcs as well as medical 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
BREXIT Support
We have extensive experience is preparing companies for BREXIT for both a deal and no deal scenario.
QP services
We have a panel of certified QPs available at short notice for short and long term assignments
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
Communication with regulatory authorities
On behalf of your company
Preparation of country specific submission documents
Such as Module 1-5 dossiers
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.
Interaction with regulatory agencies world-wide
We have extensive experience of working with regulatory agencies across the globe
CMC regulatory affairs
Preparation of Module 3 dossiers, IMPDs and also CPPs
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.
Wholesale Dealers Licences and Parallel Import Licences
We have extensive experience of gaining and maintaining wholesale dealers’ licences and parallel importers licences for multiple clients based across the EU.
Pharmacovigilance
Our dynamic and adaptable team will help you make pharmacovigilance a more streamlined process through ongoing support and tailored feedback. We offer expert advice and bespoke consultancy to assist you with a complete range of pharmacovigilance services.
Linguistic Translations
Our specialist pharmaceutical translators have extensive experience of the pharmaceuticals industry, so you can be sure your translated material will have the same attention to detail as the original language content. We will be your full-service partner and support all aspects of the drug development, launch and lifecycle process. As well as being familiar with industry guidelines and templates, our pharmaceutical translation teams use standardised specialist terminology and dictionaries in their work. Our expert in-house Account Managers have a wealth of knowledge about the industry which ensures that your project is dealt with professionally and efficiently.
CBD Products and e-Cigarettes
Cannabidiol (CBD) Containing Products
In 2016 the UK regulatory agency, The MHRA came to the opinion that products containing cannabidiol (CBD) containing more than 0.01% of THC used for medical purposes are a classified as a medicine. All medicinal products must have a valid product licence (marketing authorisation) before they can be legally sold, supplied or advertised in the UK. All Licensed medicinal products must meet safety, quality and efficacy standards to protect public health.
General rules for marketing CBD containing products in the UK that do not require the MHRAs authorisation are that the labelling should contain no medical claims, must contain the CBD content, full manufacturer details and a full list of ingredients. More importantly; the product must not contain more than 0.01% of THC.
Furthermore, EU member states regulatory authorities now regard any food, drink and food supplements that contain CBD as a “novel food”.
All Novel foods containing CBD will require a marketing authorisation. This means any company aiming to add CBD into food are required to apply to the European Commission before the commencement of marketing the product.
Examples of CBD foods in scope of novel food regulations are any CBD oils, capsules or oral sprays, CBD gummies, mints or other sweets, CBD tea, coffee, alcoholic and non-alcoholic drinks and any CBD containing snacks such as crisps or energy bars.
Oxygen Life Sciences offer a consulting service to fulfil compliance with all CBD regulations and help you bring your CBD containing products on to the UK/EU market legally.
E-Cigarettes
Oxygen Life Sciences can provide robust regulatory advice on the registration of e-cigarettes. We have experienced consultants who specialise in the TBD – Tobacco Products Directive. The Tobacco Products Directive 2014/14/EU (TPD) introduced new rules for nicotine-containing electronic cigarettes and refill containers (Article 20) from May 2016.
Our TPD consultants have backgrounds in pharmaceutical regulation. Given that e-cigarette regulation is based on pharmaceutical regulation, consultants with medical regulatory knowledge and experience are best placed to advise on the emerging e-cigarette regulations.
If you are an importer or manufacturer of e-cigarettes or e-liquids, your products must be TPD compliant before you can sell in the EU. Please contact us to find out how we can help you register legally to sell in the EU.