Interactions with authorities
Support for exchanges with the EMA, AFMPS, ANSM and West African national authorities: Scientific Advice, pre-submission meetings, responses to questions.
Our services
Healthcare regulatory affairs Europe / EMA & West Africa
SiraGroup places its expertise at the service of healthcare stakeholders who want to access European and West African markets with clarity, compliance and efficiency.
Priority service
Market accessEurope / EMA & West Africa
From regulatory analysis to go-to-market strategy, SiraGroup supports your healthcare projects across Europe, the EMA, Belgium and the UEMOA region.
Clear market access strategy
Europe / EMA & UEMOA compliance
Structured MA & CTD dossiers
Belgium · Europe · West Africa
Regulatory support for market access to Europe / EMA and West Africa
SiraGroup supports laboratories, manufacturers, distributors, healthcare project owners, partners and institutions in the preparation, structuring and management of their regulatory pathway to European, EMA, Belgian and West African / UEMOA markets — with clarity, compliance and efficiency.
Our regulatory support methodology, step by step.
- 01
Regulatory status analysis
Initial assessment of the product and its classification.
- 02
Identification of applicable requirements
Belgium, Europe / EMA, UEMOA, Burkina Faso, West Africa.
- 03
Tailored regulatory strategy
Building a roadmap fit for your target market.
- 04
Documentation support
Dossiers, consistency, quality requirements, technical content.
- 05
Procedural guidance
MA, variations, CTD, medical devices, related products.
- 06
Regulatory intelligence & watch
Monitoring regulatory changes across your markets.
- 07
Stakeholder interactions
Authorities, partners, distributors, institutions.
- 08
Market access preparation
And ongoing compliance support.
Who we serve
For whom?
- Pharmaceutical laboratories
- Manufacturers & distributors
- Healthcare start-ups, biotech, medtech
- Healthcare project owners
- Institutions & partners
- Stakeholders targeting Europe / EMA or UEMOA
Client benefits
What you gain.
- Clarify regulatory requirements market by market
- Avoid classification or procedural mistakes
- Save time preparing regulatory steps
- Reduce non-compliance risks
- Structure a realistic market access strategy
- Ease communication with partners and authorities
- Benefit from tailored support — Your Way
Sample deliverables
Concrete regulatory deliverables with immediate value.
Illustrative, non-contractual examples.
Regulatory scoping noteRequirements mappingMarket access roadmapProduct status analysisDocumentation checklistStrategic recommendationsRegulatory intelligence reportCompliance action plan
Key areas
Regulatory, scientific and technical expertise across the full product life cycle.
SiraGroup Regulatory covers the full range of healthcare regulatory affairs — from early development to post-MA maintenance — for medicines, biologics and medical devices.
- Global & local regulatory strategy
- Submissions and registration procedures
- Chemistry, Manufacturing & Controls (CMC)
- Product information & labelling
- Life cycle maintenance (variations, renewals)
- Clinical trial applications (IND / CTA)
- eCTD services & regulatory operations
- Regulatory intelligence & watch
Services portfolio
End-to-end regulatory services from strategy to submission.
From strategic scoping to submission, through to post-authorisation maintenance — each service is delivered with scientific rigour and a deep understanding of European and West African local requirements.
CMC — Medicines & Biologics
CMC strategy and documentation from development to MA: chemical, biological, biosimilars. Change control management and sustained compliance.
eCTD & regulatory operations
Preparation, structuring and submission of dossiers in eCTD format. End-to-end management with integrated quality control.
Post-MA maintenance
Variations, renewals, MA transfers following mergers & acquisitions, outsourced regulatory portfolio maintenance.
Medical devices
Classification, CE marking, technical files, MDR/IVDR compliance, support for manufacturers targeting European and UEMOA markets.
Clinical trials (CTA / CTR)
Preparation of clinical trial authorisation dossiers, transition to the CTR and submissions via CTIS.
Regulatory & Medical Writing
Scientific, technical and regulatory writing: CTD modules, SmPC/leaflet, expert reports, scoping documents.
Promotional & compliance review
Review of promotional and healthcare professional materials: compliance with the code of conduct and local requirements.
Regulatory & quality audits
Regulatory compliance audits, quality (GxP) audits, gap analysis, dossier and documentation system audits — with a prioritised action plan.
Tailored training
Training sessions for your teams: regulatory affairs, CMC, eCTD, medical devices, EMA and UEMOA specifics — on-site or remote.
Our approach
International reach, local presence.
We combine a fine reading of European requirements (EMA, national authorities) with on-the-ground knowledge of UEMOA and West African markets. Our clients thus benefit from a regionally coherent strategy, executed country by country.
Europe / EMA
27 member states
Belgium
Local presence in Wavre
UEMOA
8 West African countries
Burkina Faso
On-the-ground presence
Let's discuss your healthcare market access project.
Europe, EMA, Belgium, UEMOA, West Africa — we structure your regulatory pathway.
FAQ