Lakeside Regulatory Consulting Services

LRCS Ltd works with small companies, clinical development groups and charities to bring treatments for rare diseases to the EU. Virtual support able to represent international companies in the EU; either as their agent or by setting up a company on their behalf.


LRCS Ltd has over 25 years in Regulatory Affairs in the EU Including:

  • Regulatory strategy and submissions
  • clinical trials

Submissions and Variations for:

  • Centralized
  • Decentralized
  • Mutual Recognition procedures
  • CHMP, PRAC and CMD(h) referrals
  • Paediatric Investigation Plans (PIPs)
  • Small, Medium Enterprise (SME) status
  • Scientific advice
  • Orphan Designations

Medical Writing

Scientific writing services for:

  • Scientific Advice
  • Paediatric Investigation Plans
  • Orphan Designations
  • Community Referrals
  • Clinical and non­clinical overviews and summaries

Clinical trials applications and amendments:

  • Investigator Brochures
  • Clinical Trials Protocols
  • Clinical Study Reports
  • NICE and reimbursement support documents
  • SmPC and PIL labelling reviews