Dossier Writing : Common Technical Document (CTD) , compliant to ICH guideline and stringent regulatory Authorities like USFDA, MHRA.
ACTD (Asian Common technical Dossier) submission in Asian regions: Philippines, Thailand, Malaysia, Venezuela whole Asian territory.
NDA applications, ANDA application, Pre market approval submission as per US-FDA standards.
WHO Pre Qualifications applications and Approvals
Dossier submission in emerging potential countries like Latin America, South east African region, FMHACA Ethiopia submissions, SADC submissions, UEMOA submissions, ZAZIBONA submission in semi regulated market.
Medical devices guidelines and Standard Table of contents formatted templates for marketing authorization submission in regulated authority.
Consumables and reusable Medical devices filing USFDA, TGA, MHRA, Asian territory and semi regulated countries like UEMOA region, English African countries Ethiopia, Zambia, Tanzania, Frencho-phone regions: Burkina Faso, Cameroon, Mali, Congo RD etc.
Neutraceuticals product dossier filing in brand name marketing permissions.
Hospital Equipments marketing authorization filing with various model specifications
Standard Operating Procedure writings for Pharmacovigilence and risk assessment methodology
Art work approvals as per labeling requirements and instructions for use preparation and proof reading.
Extending vigorous efforts and direct support on facing plant site audits from authorities like FMHACA, TGA, USFDA, WHO, TFDA, ZAMRA, LMHRA etc.
