Regulatory Affairs · Market Access
From approval to access — one integrated pathway across MENA
Regulatory clearance and market access are usually run as separate workstreams, with separate timelines and separate points of failure. MSHealth runs them as one continuous pathway — so a product's regulatory strategy is built with reimbursement and payer requirements in view from day one, not retrofitted after approval.
Why one integrated service
Splitting regulatory submission from market access strategy creates a common failure point: dossiers that clear a health authority but stall at the payer stage because pricing, HTA, and reimbursement requirements were never built into the regulatory strategy. MSHealth's regulatory affairs and market access functions share the same country leads and the same submission calendar, so launch sequencing decisions are made once, with both constraints on the table.
What we deliver
Two functions, one pathway
Regulatory Affairs
Regulatory clearance built with reimbursement and payer requirements in view from day one.
- Regulatory dossier preparation and submission (registration, variations, renewals)
- Lifecycle management across product changes and labeling updates
- Compliance with EU MDR/IVDR for MedTech clients bringing devices into MENA
- Local regulatory frameworks, including AMMPS and DELM procedures in Morocco
- Pharmacovigilance system setup and ongoing case management
- Scientific and regulatory advice ahead of submission
Market Access
Launch sequencing and payer engagement run in parallel with submission, not after it.
- Pricing and reimbursement strategy by market
- Health Technology Assessment (HTA) dossier support
- Payer and national health authority engagement
- Launch sequencing across MSHealth's active markets
- Local market intelligence — competitive landscape, access precedents, payer behavior
How we work
A single calendar, sequenced by market
Assessment
Regulatory classification, target markets, and payer landscape reviewed together before a strategy is set.
Strategy
A single submission and access plan, sequenced by market.
Execution
Dossier preparation, submission, and payer engagement run in parallel, not sequentially.
Post-launch
Pharmacovigilance and pricing/reimbursement monitoring continue after market entry.
Compliance. Our regulatory and market access work is conducted under GCP, CNDP, and GDPR frameworks.
Ready to integrate your pathway to market?
Talk to our regulatory and access team — one workstream, one calendar, from approval to patient access.