Regulatory Affairs
Regulatory Affairs: Drugs and Medical Devices
From defining the regulatory strategy to post-marketing approval follow-up, Medipha Santé supports its partners in the registration and lifecycle management of their health products.
Obtaining marketing authorization
Structured support at each stage of your marketing authorization application.
1
Audit and regulatory strategy
Audit and regulatory assessment of the file
Definition of the regulatory strategy
Analysis of compliance with applicable ICH guidelines, including ICH Q1A and ICH Q3D
Development of risk management plans, where applicable
Organizing regulatory meetings with the relevant authorities
2
File composition
Structure and drafting of module 1
Drafting administrative documents
Preparation and revision of product information: Summary of Product Characteristics (SPC), package leaflet and labelling
Performing readability tests on instruction leaflets
Creation of packaging mock-ups in accordance with applicable French requirements
Preparation of the marketing authorization application dossier in CTD or eCTD format
Our teams prepare the administrative, regulatory and pharmaceutical elements necessary for the marketing authorization application.
Structure and drafting of module 1
Drafting administrative documents
Preparation and revision of product information: Summary of Product Characteristics (SPC), package leaflet and labelling
Performing readability tests on instruction leaflets
Creation of packaging mock-ups in accordance with applicable French requirements
Preparation of the marketing authorization application dossier in CTD or eCTD format
3
Publication and submission
Publishing using EXTEDO's eCTDmanager software
Submission of registration applications to the competent authorities
Management of national, decentralised and mutual recognition procedures
Management of decentralised procedures with France as the reference Member State — RMS — or as the Member State concerned — CMS
4
Procedure follow-up
File update: updates, modifications and responses to requests from the authorities
Preparation and submission of responses to questions from the relevant authorities
Monitoring the procedure until authorization is obtained
Translation of Summary of Product Characteristics (SmPC), package leaflets and other regulatory texts
Monitoring and life cycle of marketing authorizations
Our support continues after obtaining authorization in order to ensure compliance and maintenance of the marketing authorizations.
1
Regulatory maintenance
Maintenance of AMMs
Marketing Authorization Renewals
Handling of variations of types IAᴵᴺ, IA, IB and II
Transfers of Marketing Authorizations
2
Market access and security
Preparation of price and reimbursement requests
Preparation of files for submission to the HAS and CEPS
Pharmacovigilance support
3
European data and procedures
Monitoring of national phases
Submission and updating of drug-related data in accordance with the requirements of Article 57 in the xEVMPD database
Readability tests of instruction leaflets
Medipha Santé conducts readability tests to verify that the information contained in the leaflets is legible, clear and easily understandable by patients.
Design and execution of readability tests in accordance with applicable regulatory requirements
Support for initial applications, renewals or compliance procedures, according to applicable requirements
Preparation of a comprehensive report, ready to be submitted to the health authorities
Active substances
Medipha Santé supports its partners in the preparation and regulatory monitoring of files relating to active substances.
Drafting and updating ASMF files — Active Substance Master File
Regulatory evaluation of files
Submission and monitoring of ASMFs with the competent authorities within the framework of the relevant MA or variation procedures
Preparation and submission of CEP applications — Certificate of conformity to the monographs of the European Pharmacopoeia — to the DEQM/EDQM
Following procedures and preparing responses to questions from the authorities
At each stage, Medipha Santé assesses your case and assists you in drafting, submitting and monitoring your applications with the relevant authorities.
Medical devices
Compliance with Regulation (EU) 2017/745
We support manufacturers in their regulatory processes and in bringing their medical devices into compliance.
Support in the CE marking process
Support for registration and certification, where applicable
Preparation and updating of technical documentation
Implementation of mandatory regulatory procedures
Support related to the quality management system
Regulatory and medical translation
Our in-house experts are proficient in the scientific, medical, and regulatory terminology applicable to health products. They use the most up-to-date models, dictionaries, and terminological reference databases.
Our translations are carried out in accordance with the EMA's QRD models, current French models, and the applicable requirements for writing and presenting product information. Our teams also rely on standard DEQM/EDQM terms and reference medical terminologies, including MeSH.
1
Product information
Summary of Product Characteristics — SPC
Patient information leaflets
Labels and other packaging elements
2
Regulatory and clinical documentation
Modules 1, 2, 3, 4 and 5 of the marketing authorization dossiers
Documentation relating to clinical studies
Expert reports
Overviews and summaries relating to quality, as well as clinical and non-clinical sections
3
Quality and industrial documentation
Standard operating procedures — SOP
Review, checking and validation of documentation
Manufacturing batch records