Innovative Medicines

Leading innovative medicines

team advising pharmaceutical

companies on the legal and

regulatory issues surrounding

the development and delivery

of innovative medicines.

The remarkable team of innovative medicines lawyers at our law firm is at the cutting edge of the legal and regulatory issues facing organisations using AI, emerging technologies and software with the aim of shortening the developmental cycle of certain medicines involved in the groundbreaking development of next generation medicines. There are a number of challenges facing pharmaceutical companies conducting research and development as well as the delivery and supply of an innovative medicine and at our law firm we have assembled a multidisciplinary team comprising life sciences and pharmaceutical lawyers and industry led experts who are well placed to advise and assist from the research & development stage to the delivery and supply of your innovative medicines.

If you are investigating rare, chronic or infectious diseases an innovative medicine solicitor will be able to advise and assist you with the legal and regulatory aspects throughout the life cycle of the innovative medicines from innovative R&D to delivery and supply of such innovative medicines including intellectual property protection, clinical trials, manufacture and supply, regulatory compliance, AI, digital technologies, patient data management and mathematical modelling.

Our innovative medicine lawyers have expertise in advising and assisting spin out companies and universities on the delivery of groundbreaking technologies and antimicrobial medicines. Our innovative medicines multidisciplinary team has advised and assisted partnerships and organisations in the life sciences, pharmaceutical and biotechnology industry sectors involved in collaborative projects for the development of new treatments advising on and drafting collaborative agreements between universities, pharmaceutical companies, spin outs, research organisations and biotechnology companies.

Therapeutic advantages for the Treatment of Illnesses with New Tools and Methodologies for specific Medicines:

Antimicrobial Resistance
- New Antibiotics for Resistant Infections
Chronic Diseases
- Chronic Obstructive Pulmonary Disease
Infectious Diseases
Rare Diseases
- Orphan Disease.
- Orphan Drugs
Using Artificial Intelligence to select the best Cancer Treatment
Antimicrobial Resistance
Research into Biological Markers for Neurodegenerative Diseases
Development of Diagnosis for Rare Disease
Use of Artificial Intelligence to identify Rare Disease Patients.

Our Services

Our legal and regulatory services in innovative medicines include:

Artificial Intelligence, Research and Development	Advising and assisting with: AI Technology to Determine the Mechanisms of Novel Innovative Medicines or Vaccines Medical Research Novel Therapies Patients’ Electronic Health Records for Research Purposes Scientific Information Management
Clinical Trials	Advise and assist you in relation to the legal issues surrounding running Clinical Trials Clinical Trial Agreements Patient Data Management Regulatory Compliance.
Commercial Contracts, Licensing, Joint Ventures, Mergers and Acquisitions	Acquisition and Disposal of Business Acquisition and Disposal of Shares Asset Purchase Agreements Brand Acquisition Collaborative Agreements Consultancy Agreements Data Monitoring Due Diligence Heads of Agreement Joint Ventures Licensing Mergers and Acquisitions Manufacturing Agreements Misleading Advertising. Supply Agreements
Dossiers	Advising and assisting with: Advising and assisting with the pPreparation of Registration Dossiers for Innovative Medicines or Vaccines Liaising with the MHRA for Approval of Innovative Medicines or Vaccines Approval of Innovative Medicines or Vaccines from the MHRA
Intellectual Property	Intellectual Property Protection in relation to the Patenting of Biosequences and Chemical Structures IP Assignments IP Licensing IP Strategies Diagnostic Patents Patenting of Vaccine Technologies Mechanical IP Patent Litigation
Manufacturing	Advise and assist you with obtaining the requisite Manufacturing Licence Advice and assistance on the Legal and Regulatory Processes and Requirements GMP Advising on SOPs Manufacturing Process to ensure the Products meet the requisite standards of Quality, Efficacy and Safety Steps to be taken to ensure Compliance Labelling and Packaging Patient Information Leaflet Production and Packing Summary of Product Characteristics.
Regulatory Compliance: Marketing, Selling, Offer for Sale or Supplying Products	Advise and assist you with Regulatory Compliance to obtain the requisite Marketing Authorisations Steps to be taken to ensure Regulatory Compliance Drafting documentation including SOPs Advice and assistance on the Legal and Regulatory Processes and Requirements Summary of Product Characteristics Patient information Leaflet Restrictions on Selling.
Testing	Advise and assist with: Preclinical Pharmacological and Toxicological Compliance Testing Agreements: 'in vitro' and 'in vivo' Testing Safety Compliance