Navigating global drug regulations is complex—Cogniwell simplifies it. Our end-to-end regulatory expertise ensures seamless market entry across 50+ countries, from dossier compilation (CTD/eCTD) to post-approval compliance. Whether it’s FDA 505(b)(2), EMA hybrid applications, or emerging market approvals, we turn regulatory hurdles into competitive advantages. Fast-track your exports with a partner who speaks the language of compliance fluently.
Regulatory Mastery & Export Readiness
Regulatory delays cost pharma companies $1M+ per month in missed opportunities (Deloitte 2023). Cogniwell’s "Compliance by Design" approach embeds regulatory intelligence upfront, minimizing rejections. Our services include:
We go beyond traditional consultancies by pre-empting agency pain points—e.g., our proprietary gap-analysis algorithm flags stability study discrepancies before submission, cutting review cycles by 30%. A recent case: Secured South African SAHPRA approval in 5 months (benchmark: 9+ months) for a client’s oncology generic by pre-packaging local clinical waiver evidence.
Your Benefit: Faster revenue realization, reduced compliance overhead, and a partner who transforms regulatory strategy from a cost center to a market-shaping tool.