Pre-Submission Regulatory Activities
Product classification and regulatory pathway determination.
Data requirement mapping (clinical, quality, bioequivalence, stability).
Comprehensive dossier gap analysis
Regulatory intelligence on timelines, fees, and country-specific requirements.
Guidance on GMP, API, and CPP documentation readiness.
Dossier Preparation
Compilation and formatting in CTD structures.
Module 1 authoring and country-specific localization.
Review and refinement of Module 2 (QOS, QIS, BE summaries).
Alignment with global standards (ICH, WHO) and local regulatory requirements.
Conversion from ACTD to eCTD formats.
Submission Management
Preparation of application forms and administrative documentation.
Structuring of submission-ready CTD dossiers.
Electronic submissions via regulatory portals (where applicable).
Physical dossier submissions in East Africa.
Local regulatory representation for foreign MAHs within East Africa.
Query & Assessment Management
Drafting of scientific and regulatory responses to authority queries.
Preparation of technical justifications and supporting documentation.
Management of rolling reviews and submissions.
Proactive follow-up to support timely approvals.
Approval & Post-Approval Support
Receipt and verification of registration certificates.
Management of conditions of approval and regulatory commitments.
Submission of post-approval documentation and follow-up requirements.
A single, accountable partner for seamless regulatory execution-from strategy to approval and beyond.