Pharmaceutical Development Programs and Clinical Trial Designs

Consultancy Service

Consultancy
Service

Project Managing

Project
Managing

Document Support

Document
Support

In 2008 Paul Smith established Professional Regulatory Services Ltd. 

Regulatory Science for New Medicines

Services

PRS provides services to the pharmaceutical industry. 
Companies rely on PRS to consult on regulatory aspects of new product development, maximising value and leverage.   

New Medicines Development

Expert consulting helps to develop new medicines, supporting companies in a streamlined and effective solution. 

Mechanisms of Action

Today new medicines contain a greater diversity of types of active substances than ever.  They range from chemical small molecules to traditional biologics and to various biotechnology-derived substances. Recently products containing manipulated cells or viruses account for more enquiries from clients.

The regulatory environment shifts every couple of years; the emphasis of interests and leading edge of company activity reflects the newest legislation and its implications for companies and stakeholders. For example, paediatric investigation plans and their related clinical trial design issues no longer seem to be looming liabilities. 

In the present climate enquiries are more likely to be concerned with cell donor eligibility, or, the managed disclosure of clinical trials and results-related product development information.  As ever, the fastest route to FIH (first in human) is a question from firms of any size.     

We are all shaped by our experiences and they help to make us individual. When companies want consulting from an individual, as opposed to a brand, PRS may come to mind because companies are assured of personal continuity and respect.

PRS is a director-owned private limited company for this consulting work.

Projects Types

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blood cells

The consulting activities and project types in this website are neither comprehensive nor exhaustive.  New enquiries about drug development support or know-how are welcome.

Some examples of our projects include:

  • Scientific advice procedures and protocol assistance procedures
  • Drafting Quality & Pharmacy information 
  • Clinical Trial Authorizations
  • Eligibility agreements to the centralised procedure  
  • SME Declarations on behalf of drug sponsors and consultancies
  • Drafting documents for CTD module two    
  • Medical writing  
  • Consulting on new legislation and emerging technologies
  • Preparing Paediatric Investigation Plans
  • Consulting on global regulatory strategy 

To find out more about consulting, project management and document support to help your medicine get approved for the EU or US market, click on the Contact tab.