Regulatory Strategy & Market Access

Design and execute regulatory pathways that align product strategy with target-market requirements. For biopharma clients we map FDA and EMA submission strategies (IND/CTA, CTD/CMC components); for device and agro clients we prepare dossiers and local registration strategies for Ghana and regional African markets.

 

Key offerings

• Regulatory pathway assessment and strategy (FDA, EMA, national agencies)

• Dossier and submission readiness (CTD/CMC, technical files, local registration packs)

• Labeling, claims and promotional compliance reviews

• Regulatory liaison and submission management support
   

Typical deliverables

• Regulatory roadmap with milestones and resourcing plan

• Submission checklist and dossier package review

• Labeling and claims compliance report

• Regulator interaction plan and briefing materials
   

Client impact / outcomes

• Shorter, de-risked time-to-filing and fewer submission deficiencies

• Clear milestone plan to support commercial launch decisions and investor updates