Rare Diseases

Leading rare diseases team

advising and assisting pharma

and biotechnology companies

in the research & development,

diagnosis, treatment, manufacturing

and supply of medicines for rare

diseases.

The outstanding rare diseases lawyers at our law firm are experts in life sciences and pharmaceuticals law. A lawyer specialising in rare diseases will advise and assist you whether you are a pharmaceutical, a small and medium biotechnology or IT company involved in the diagnosis, treatment, manufacturing and supply of medicines for rare diseases. The rare diseases team at RT Coopers comprises scientists with first-hand experience of conducting research as well as working in the pharmaceutical and biopharmaceutical industry sectors. Therefore, our law firm has assembled a rare diseases team that appreciates that there are many conditions with currently no treatment and that there is still a lack of epidemiological, clinical and health economics data for most rare diseases. There is clearly reduced access to rare diseases medicines such as orphan drugs because of the lack of relevant knowledge, expertise and treatment for rare diseases limited patient numbers.

Rare diseases are defined as diseases with a particularly low prevalence affecting the lives of individual. In the UK alone this affects around 3 million people. Hence, the diagnosis and treatment of rare diseases is a global issue requiring cross border strategic partnerships to ensure the continuing development of new medicines to treat these diseases.

A rare disease lawyer will be able to advise and assist you if you are at the stage of R&D on rare diseases to bring to market treatments and therapies or supplying and distributing medicines such as Orphan Medicinal Products to treat rare diseases.

Our rare diseases lawyers are cognisant of the issues facing companies conducting research and development, the prevention, diagnosis and treatment of rare diseases.

Types of Rare Diseases and Genetic Diseases

Rare Cancers
Auto-immune Diseases
Congenital Malformations
Toxic and Infectious Diseases

Causes and Mechanisms of Common Conditions

Infections, Allergies, Deterioration of body tissues and organs and Teratogenic effects
Rare Diseases can cause Obesity and Diabetes
Model of Dysfunction of a Single Biological Pathway
Genomics
Management of Rare Diseases

Our Services

Our legal and regulatory services in rare diseases medicines include the following areas that we will advise and assist you with:

Use of Artificial Intelligence	AI Technology to Determine the Mechanisms of Novel Rare Diseases Medicines or Vaccines with AI Technologies Novel Therapies Scientific Information Management
Clinical Trials	Legal issues urrounding running Clinical Trials Clinical Development Clinical Trial Agreements Patient Data Management Regulatory Compliance
Commercial Contracts,	Acquisition and Disposal of Business Acquisition and Disposal of Shares Asset Purchase Agreements Brand Acquisition Collaborative Agreements Consultancy Agreements Joint Ventures Licensing Manufacturing Agreements Mergers and Acquisitions Supply Agreements
Diagnosis of Rare Disease	Bioinformatic and Clinical Evaluation Diagnostic Tools DNA-based Diagnosis Next Generation Sequencing
Dossiers	Preparation of Registration Dossiers for Rare Diseases Medicines or Vaccines Liaising with the MHRA for Approval of Rare Diseases or Vaccines Approval of Rare Diseases 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
Research & Development	Development of Clinical Research in the field of Rare Diseases Development of Therapies Development of New Technology Drug development into Rare Diseases Genetic Research Development of Orphan Medicinal Products Rare Diseases Primary Preventitive Measures
Regulatory Compliance: Marketing, Selling, Offer for Sale or Supplying Products	Gene Therapy 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 Biological Products or Small Molecules Stem Cell derived Approaches Rare Diseases Registration
Testing	Generic Testing Preclinical Pharmacological and Toxicological Compliance Testing Agreements: 'in vitro' and 'in vivo' Testing Safety Compliance

Related Areas

Antimicrobial Resistance
CBD: Cannabidiol Products
Clinical Trials
Commercial Contracts
Corporate Finance
Diseases
Genomic Medicines
Herbal Medicines
Household & Consumer Product Regulatory
Innovative Medicines
Intellectual Property
Life Sciences
Medical Devices
Pharmaceuticals
Vaccines
Virtual R&D

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

For more Testimonials on life sciences and biotechnology, pharmaceuticals and antimicrobial resistance.