Last update Jan 2014
Advisory, Product Support and Training Services

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Regulatory strategy, advice, dossier preparation and gap analysis

Regulatory strategy, advice, dossier writing, review and gap analysis for EU Marketing Authorisation Procedures and Applications

  • Scientific advice meetings
  • Procedural advice and liaison with regulatory authorities
  • Legal base for applications
  • UK national applications
  • Mutual Recognition Procedure (MRP) applications
  • Decentralised Procedure (DCP) applications
  • Centralised Procedure (CP) applications
  • New active substances
  • Novel dosage forms
  • Line extensions
  • Abridged / generic applications
  • Drug / device combinations
  • The Common Technical Document (CTD)
  • Quality Overall Summary (QOS) (CTD Module 2.3) and signature
  • Summary of Product Characteristics (SPC, SmPC)
  • Labels and leaflets
  • Appeals (written representations, hearings)
  • Pre-submission assessments / review of documents / gap analysis
  • Advice on responses to deficiency letters / requests for further information (RFIs)
  • Variation applications

Dr Mike Robertson has varied and extensive experiences in pre- and post- licensing activities for gaining and maintaining Marketing Authorisations (MAs) or Product Licences (PLs) and is supported as necessary by an extensive network of associates, many of whom have, like Mike, formerly worked as regulators in European Competent Authorities.