Our core business: The MA dossier
Nearly fifteen years of experience in the regulatory affairs, working in close collaboration with national and international agencies means we master the complexity of both regulatory and market access concerns.
Through our many missions in various therapeutic fields, we have built a strong network of experts and internationally recognized clinicians.
We cover all aspects of regulatory affairs from consulting to comprehensive service provision.
STRATEGIC MARKET ANALYSIS
Registration strategies :
New products, Hybride, Generics
OTC, Herbal products, Homeopathy
Drug device combination
Change in status :
Custom Regulatory monitoring
Audit and gap analysis
Writing of CTD Module : M1 to M5 / Technical file for MD
Expertise (quality, non-clinical and clinical)
Risk management plan
Environmental Risk Assessment
SUPPORT FOR REGISTRATION
Compilation and publishing (eCTD)
Registration management (DCP / MRP / National / Centralized)
Responses to Questions / Coordination with Authorities
Leaflet Readability test
Variations / Product information changes (NSPC, Leaflet, Labelling)
Pharmacovigilance (PSUR, LQPPV, PDE …)
Quality (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 ;