Our services

eCTD and Regulatory Procedures Management

RPN staff have wide experience in the preparation of eCTD and management of the regulatory procedures (e.g. Marketing Authorisation Applications, variations and renewals).

RPN services are:

  • Support for the preparation of registration dossiers including critical sections (e.g. Pharmacovigilance System Master File, Risk Management Plan, Environmental Risk Assessment)
  • Advise on different national requirements for the submission of Marketing Authorisation Applications
  • Assistance in writing response documents to authority deficiency letters/list of questions
  • Assistance in preparing and attending oral hearings with the authority during procedures
  • Assistance in updating dossier sections in response to authority deficiency letters during Marketing Authorisation procedures
  • Preparation of CTDs
  • Preparation of eCTD or non-eCTD electronic submission (NeeS)
  • Management of e-submissions, whether eCTD or (NeeS)
  • Assessment of eCTD or NeeS applications for compliance prior to submission
  • Preparation, submission and management of variation, renewal and Marketing Authorisation Holder Transfer applications
  • Preparation, submission and management (through local agent) of application procedures in the USA: IND, NDA, ANDA or DMF
  • Proxy service with national authorities

Facilitation of local concerns via a network of partners in EU countries and USA

Consolidated network of partners in EU countries and a local Agent in the USA allow us to support our clients facing specific local issues.