Vaccines

Leading vaccine

& regulatory team

of phenomenal vaccine

lawyers and technical

experts with the legal

and technical knowledge

to advise and assist your

company successfully from

research & development,

the regulatory process to

the manufacturing and supply

of vaccines.

Our leading vaccine team comprise vaccine lawyers and regulatory experts who will advise and assist your company during the research & development of new vaccines, antibody research, protein sequencing and/or in securing marketing authorisations from the Medicines and Healthcare products Regulatory Agency (‘MHRA’), in order to develop, manufacture and place new vaccines for infectious diseases on the market in the UK. Any new vaccines including pandemic vaccines must be approved before they can be released on the market.

The vaccine lawyers at our law firm have worked in the pharmaceutical and biotechnology industry in the development of vaccines and in carrying out clinical trials and can bring amazing insight to your trials if your company is designing, conducting, recording and reporting trials that involve the participation of human subjects..

Our life sciences lawyers will advise and assist your vaccine company through the regulatory process to ensure that your results (derived from the data collected during the product development and clinical trials) meet the requisite quality, efficacy and safety for new vaccines.

Our vaccine lawyers will assist with the evaluation of the clinical and non-clinical data to be submitted in your dossier in the application for marketing authorisations.

Our Services

Artificial Intelligence	Advise and assist with AI Technology to Determine the Mechanisms of Novel Drugs Novel Therapies Scientific Information Management
Clinical Trials of Vaccines	Clinical Trial Agreements (Phase I study, Phase II study, Phase III study and Phase IV studies) Ethical and other Approval Good Clinical Practice Advice on the Management of Clinical Trials for Vaccines Approval from the MHRA
Commercial Contracts & Corporate Finance	Collaboration Agreements Joint Ventures Licensing Agreements Mergers & Acquisitions R & D Agreements
Development	Preclinical and/or Clinical Development of Vaccines R & D Agreements
Dossier	Preparation of Registration Dossier for Vaccines Liaising with the MHRA for Approval of Vaccines Approval of Vaccines from the MHRA
Evaluation of Clinical and Non clinical Data	Evaluation of clinical and Non clinical Data Clinical Evaluation of Vaccines for pre- and post-exposure prophylaxis against Infectious Diseases Inspections
Good Manufacturing Practice (‘GMP’)	To ensure compliance with GMP
Intellectual Property	Intellectual Property Protection in relation to the Patenting of Biosequences and Chemical Structures IP Assignments IP Licensing IP Strategies Compulsory Licensing Diagnostic Patents Patenting of Vaccine Technologies Mechanical IP Patent Litigation
Licensing	Cross Border Transactions IP Licensing Licensing of Vaccines Licensing Agreements
Manufacturing and Supply of Vaccines	Commercial Contracts including Manufacturing and Supply Agreements Cross Border Transactions Mergers and Acquisitions Intellectual Property Regulatory Requirements
Marketing Authorisations	Advice and assistance with the application for Marketing Authorisations for Vaccines Renewals of Marketing Authorisations Variations to the Original Marketing Authorisation
Post Marketing Authorisation	Pharmacovigilance Advice on Safety Reporting Post MA commitments
Regulatory Approval	Attaining Regulatory Approval for Vaccines
Testing	Preclinical Pharmacological and Toxicological Compliance Testing Agreements: 'in vitro' and 'in vivo' Testing Safety Compliance

Related Services

Brochures

Pharmaceuticals

Articles

REACH: Restrictions imposed on the Use of Phthalates in Plasticised Materials, July 2019
Online Pharmacies: Guidance for Registered Pharmacies providing Pharmacy Services at a Distance including on the Internet, June 2019
Intellectual Property: Design and Trade Mark Law changes- no deal Brexit Guidance, April 2019
Placing manufactured goods on the EU and UK internal markets-no deal Brexit guidance, March 2019
Food Safety: Guidance on Food Traceability, Withdrawals and Recalls within the UK Food Industry, March 2019
MHRA submissions if NO DEAL BREXIT guidance: Making submissions to the MHRA in a no deal scenario, March 2019
Regulation of Medical Devices, September 2018
Generic Medicines: Data Exclusivity, May 2013
Pharmaceutical Advertising on the Internet, June 2011
Advertising Pharmaceutical Products, December 2009

Testimonials

DNA Diagnostics Centre

‘We really appreciated RT Coopers professional expertise regarding a project they assisted with. Detailed and structured feedback was crucial and very important to our innovative concept. I will definitely revert back to Rosanna and the team on other projects in the near future.’ Daniell Leigh, Director

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Testimonials

Ice Healthcare Ltd

“RT Coopers Solicitors operate in the real world and deliver what they say they’ll deliver. A highly responsive, straight talking, client focused team who will pull out all the stops to deliver on-time results of the highest standard. Definitely a team you want along side you when the going gets tough. I think that says it all…...” Janet Dean, Operations Director

For more Testimonials on life sciences and biotechnology