Regulatory affairs: Medicines and medical devices

To meet the registration needs of medicines or active substances, Medipha Santé offers its clients the following services:

Application for marketing authorisation (MA) of medicines (human and veterinary use)

  • Audit / Evaluation of the file
  • Constitution of module 1
  • Drafting of administrative parts (including SSPCs, package leaflet and labels)
  • Carrying out the readability test of the notices
  • Making models for filing according to the mandatory requirements for packaging in France
  • Drafting of the MA-file in CTD format
  • Publishing : Using Extedo’s eCTDmanager software 
  • Submission of registration applications to authorities (national procedures, DCP, MRP)
  • Updating the file (updating, modification, answering questions from the authorities, etc.)
  • Follow-up of the procedure with the authorities until the authorisation is obtained
  • Translation of texts (SPC/Notices)
  • Organisation of decentralised procedures with France as reference member state (RMS)
  • Regulatory strategy (ICH compliance, Q3D, Q1A, PGP, etc.)

Since 2004, we have filed more than 100 MA applications per year.

Follow-up of MAs

  • Maintenance of MAs
  • MA-renewals
  • Variations (types IAIN, IA, IA, IB and II)
  • Transfers of MAs
  • Price and reimbursement requests (HAS and CEPS Dossiers)
  • Pharmacovigilance 
  • Monitoring of national phases
  • Inclusion of medicinal products in the European electronic dictionary (Article 57-XEVMPD)

Readability tests of notices

  • Readability tests in French and English

We carry out for you the readability test of the notices that has become mandatory for any initial application or renewal of Marketing Authorization (MA) since the implementation of the European Directive 2004/27/EC. We provide our clients with a report ready to be sent to the health authorities.

Active substances

  • Drafting of ASMF Dossiers
  • Regulatory evaluation of the Dossier
  • Submission of the application Dossier to the EDQM (CEPS) or to concerned member state (CMS)
  • Follow-up of the procedure with the authorities

At each step, Medipha Santé evaluates your Dossier and provides you with assistance in writing, submitting and following-up your requests to the authorities.

Medical Devices (European Regulation 2017/745) :

  • CE marking
  • Registration / Certification
  • Preparation of technical files
  • Mandatory procedures
  • Total quality assurance

Our inhouse experts have access to the latest terminology, dictionaries, databases, and are well acquainted with regulatory issues. Their translations meet the requirements under the current EMA Quality Review of Documents (QRD) template, current French Template and requirements for editing/preparing/submission of Product Information and related standards (i.e: excipients with known effect, EDQM’s “Standard Terms”, the INSERM’s Medical Subject Headings (MeSH), etc.)

We offer you, among other things, the following translation services :

  • Product information (Summary of Product Characteristics (SmPC):  package leaflets, labelling)
  • Technical documentations (Module 1, Module 2, Module 3, Module 4 and Module 5 of Marketing Authorisation dossiers)
  • Clinical study documentation
  • Expert reports
  • Quality, Clinical and Non-clinical overviews and summaries
  • Standard Operating Procedures (SOP)
  • Validation documentation
  • Batch Manufacturing Records