Notre cœur de métier : le dossier d’AMM
Près de quinze ans d’expérience dans le domaine pharmaceutique en collaboration étroite avec les agences nationales et internationales nous a permis de maîtriser la complexité du domaine réglementaire et de l’accès au marché.
De nombreuses missions dans des domaines thérapeutiques variés nous ont aidés à construire un réseau d’experts et de cliniciens internationaux reconnus.
Du conseil à la prise en charge globale, nous couvrons l’ensemble des aspects réglementaires.
ODD
QPPV
PIL
RMP
CTD
IMPD
MA
IMPD
eCTD
ODD
QPPV
CTD
PIP
CTD
PSUR
PIL
RMP
Analyse stratégique des marchés
Stratégie d’enregistrement
Nouveau produits, Hybrides
Protéines recombinantes
Génériques, OTC, combinaison de produits
Plantes, Homéopathie
Évolution des statuts
Switch OTC / délitage
Dispositif médical
Conseil réglementaire personnalisé
Études de casExpertise réglementaire
Audit et gap analysis
Recherche bibliographique
Rédaction Module 1 à Module 5
Expertises (qualité, préclinique et clinique)
Plan de gestion de risque
Évaluation des risques environnementaux
Support à l’enregistrement
Préparation et participation aux réunions de pré-soumission
Compilation et soumission des dossiers (version papier/NeeS/eCTD)
Gestion des enregistrements (DCP, MRP, National, Centralisée)
Préparation et coordination des réponses aux questions, suivi auprès des agences
Test de lisibilité de notice
Lifecycle management
Compliance réglementaire
Renouvellement d’AMM
Variations / DMI (RCP, Notice, Étiquetage)
Pharmacovigilance (PSUR, LQPPV, PDE …)
Qualité (Audit, Due diligence, PQR, …)
ASMF / CEP / USDMF
Preparation of a Rx-to-OTC Switch (change of prescription status).
Feasibility study. Securtiy and safety profile analysis.
A European pharmaceutical Company intending to switch an anti-allergic product from Rx status to OTC.
- Market analysis ;
- Analysis of the non-clinical, clinical and pharmacovigilance data. Feasibility assessment ;
- Recommendations on the procedure ;
- Development of the switch rationale ;
- Marketing strategy development (+ Leaflet User testing) ;
- Writing of switch dossier, submission and follow-up of procedure with the Authorities ;
- Support until the approval ;
Writing of strategic file before MA (e.g. ODD, PRIME…)
Organization of the regulatory consultation (EMA, and/or European national authorities).
Preparation of medical writing and support for ODD and PRIME procedure.
A US biotech company is about to finish the development of a new product and needs support to develop new chemical entities in Europe for orphan diseases.
- Definition of the optimal regulatory strategy + consultation (scientific advice) ;
- Preparation of documentation ;
- Writing of the initial file ;
- Submission and responses to questions of the authorities ;
- Management of the necessary activities after the initial authorization ;
ReWriting of a complete Module 3 and 2.3 (QOS).
A subsidiary of an international Big Pharma wishes to subcontract update of its complete pharmaceutical dossier.
- Gap analysis between the MA Dossier / the production (e.g. the batch records and analytical procedures for manufacturing sites) and the current guidelines ;
- Variation strategy proposition ;
- Update of the module 3 ;
- Writing of the module 2.3 (if necessary) ;
- Electronic formatting (eCTD) and submission ;
- Response to questions from the agencies ;
Writing of a non-clinical overview (Module 2.4 and 2.6)
Writing of a clinical overview (Module 2.5 and 2.7)
An injectable products specialist for hospital market give to us :
The writing of the non-clinical and clinical parts for an initial submission in Europe.
The Update of an existing dossier for an extension of the indication with addition of new clinical or toxicological datas.
- Literature research and selection of the literature reference ;
- Regulatory strategy analysis and recommandations ;
- Complete writing of modules 2.4, 2.5, 2.6 and 2.7 (with formatting to eCTD) ;
- Preparation and drafting of the documentation for clinical trials ;
- Signature of Modules 1.4.2 (Non-Clinical) and 1.4.3. (Clinical) ;
- Follow-up with the agencies ;
ASMF redaction and update
An international API company wishes to subcontract its ASMF administration for several countries in Europe and Export.
- Management of an ASMF on behalf of the producer (export)
- Audit, redaction of the update (closed and open part) ;
- Submission to the authorities and follow-up (UE and export) ;
- Management of the follow up between customers, producers and the authorities ;
Completion of 20 dossiers and management of the registration in more than 10 countries.
Long term mission in 6 years.
A subsidiary of an Italian company wants to outsource the management of all its export MA from France
- Analysis of the local regulatory requirements ;
- Completion of the dossiers ;
- Registration of the variations / Update ;
- Transmission of the dossier to local partners ;
- Creation of dashboard ;
Regulatory compliance /
Request for Product Modification Change
3 international pharmaceutical key players have to update their medical information to comply with regulatory requirements (SmPC, Labelling and Leaflet)
- Medical information comparison between the selected products ;
- Consideration of all the reference texts (e.g. QRD template, thesaurus, etc…) ;
- Annex I, II, IIIA and IIIB preparation (+Leaflet user testing if necessary) ;
- Preparation of the variation ;
- eCTD submission ;
- Follow-up with the authorities ;
Evaluation of the Product Quality Review (PQR) on behalf of the Marketing Holder.
Long term mission in 3 years.
A major actor in France requires to have an analysis of its PQRs
- Support to the owner for the PQR review ;
- Control of relevance of the data in regards to the GMP requirements (CAPAs, Commitments, on-going stability, OOS, OOT, contract …) ;
- OOS/OOT identifications ;
- Synthesis and alert if necessary ;
- Conclusion ;
Local QPPV (Qualified Person for PharmacoVigilance)
A subsidiary of an American major company wants to outsource the administration of its local Pharmacovigilance
- Coordination with the global PV Customer and with the authorities ;
- In charge of the local Pharmacovigilance activities ;
- Writing of the local PV procedure / Signal detection ;
- Follow-up of the adverse events for France ;
- Weekly monitoring of the literature ;
- Follow-up of the complaints ;
- PSUR management ;
- Follow-up and treatment of the off label use ;
- R.T.U ;
