Abba Pharma Limited holds operating licences facilitating market access during the registration and post marketing phases.
Find Out MoreAbba Pharma Limited holds operating licences facilitating market access during the registration and post marketing phases. We support logistics and supply chain management, compliant with GDP.
| Regulatory Approvals | Variation Filings | Post Approval Submissions | Regulatory & Technical Writing | Quality Assurance / Compliance |
|---|---|---|---|---|
| Periodic updates on new / draft guidelines | Minor / major notifications and amendments | Annual Reports | Clinical & CMC reports (CTD) | Due Diligence, Gap Analysis |
| Classification / Filing Strategy | Type I and II variations - process change, site variation, source variation, others | PSURs | Conversion of CTD to eCTD and submission to various global agencies | GXP Audits |
| Scientific Consultation - Agency / Experts | Acquired dossiers - MAA transfers across geographies | Justifications and rationale | Manufacturing change assessment, regulatory impact across markets | |
| SEC Meetings | ||||
| Analysis and submission of relevant regulatory data to Experts Committees to garner favorable outcomes (eg: Recommendations / Waivers, etc) | Shelf life extensions Additional Indications and precausentations Packaging. Labeling changes |
Literature search | Prescribing Information / Package Inserts compliance Labeling and promotional material due diligence |
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