Antimicrobial Resistance (AMR) in Human Medicine

Elite antimicrobial 

resistance lawyers 

advising on the legal

and regulatory aspects

of R&D to the supply 

of novel antimicrobial

medicines and vaccines

 

 

The leading antimicrobial resistance lawyers will advise and assist you with your initiatives to develop, manufacture and supply antimicrobial medicines. The antimicrobial resistance multidisciplinary team at our law firm comprises scientists with first-hand experience of conducting research as well as working in the pharmaceutical and biopharmaceutical industry sector.  Our antimicrobial resistance team is well placed to guide you on legal and regulatory issues that may arise during the development of novel antimicrobial medicines and vaccines aimed at limiting resistance or reducing the emergence and spread of antimicrobial resistance. 

 

Antimicrobial resistance occurs when microbes evolve to become more or fully resistant to antimicrobials which previously could treat them such as antibiotics. As pathogens become resistant to antimicrobials the chances of treating infections are substantially reduced. Our AMR team is cognisant of the urgent threat of antimicrobial resistance, posed by the emerging and steady increase of microbes that are resistant to antimicrobial treatments including the threat to the effective treatment of infectious diseases. Accordingly, our antimicrobial resistance lawyers have the knowledge and expertise to advise and assist you and to provide the highest quality legal and regulatory advice whether you are a research-based pharmaceutical company or a biotechnology company; once you are  involved in the development of  innovative new medicines, new diagnostic tests and/or utilising antibacterial clinical development.  

 

 

 

 

The antimicrobial resistance team comprises lawyers and scientists with doctorates and post doctorates and as such appreciate that as existing antimicrobial medicines become obsolete, due to resistance, you continue to research and develop novel antimicrobial medicines and vaccines. 

 

Innovation, Research & Development, Development of Treatments and Therapies

• Antibacterial Clinical Development
  • Preclinical and Clinical Data
• Antimicrobial Medicines
  • Bacterial and Fungal Infections
• Antimicrobial R&D
  • Development of New Medicines and Treatment  
  • Drug development for Novel Antibacterial Agents
  • Non-Antibiotics and Antibiotics
• Anti-Virulence Agents
• Biological Agents
• Combination Therapies
• Healthcare Delivery Systems
• Innovation in the Development of New Antibiotics
• New Diagnostic Tests 
• Monoclonal Antibodies and Vaccines on Antimicrobial Resistance 
  • Development of Mathematical Models 
• Vaccines.

 

 

Our Services

Our legal and regulatory services in connection with antimicrobial resistance include:

Artificial Intelligence	Advise and Assist with: AI Technology to Determine the Mechanisms of Novel Antimicrobial Medicines or Vaccines  Novel Therapies 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 Distribution Agreements Due Diligence Heads of Agreement Joint Ventures Licensing Mergers and Acquisitions Manufacturing Agreements Misleading Advertising. Supply Agreements
Dossier	Preparation of Registration Dossier for Antimicrobial Medicines or Vaccines Liaising with the MHRA for Approval of Antimicrobial Medicines or Vaccines Approval of Antimicrobial 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 Compulsory Licensing 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	Preclinical Pharmacological and Toxicological Compliance Testing Agreements: 'in vitro' and 'in vivo' Testing Safety Compliance

Related Areas

 

• Agrochemicals
• CBD: Cannabidiol Products
• Clinical Trials
• Commercial Contracts
• Corporate Finance
• Diseases
  • Chronic Diseases
  • Infectious Diseases
  • Rare Diseases
• Herbal Medicines
• Household & Consumer Product Regulatory 
• Innovative Medicine
• Intellectual Property
• Life Sciences
• Medical Devices
• Pharmaceuticals
• Plant Protection Products
• Vaccines
• Virtual R&D

 

 

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, pharmaceuticals and antimicrobial resistance.