Regulatory Affairs Services

PharOS Ltd. offers a wide range of services which includes regulatory affairs. Features: it enables to ensure that your dossier reaches marketing authorization status at the most time efficient and cost effective manner. Functional submissions outsourcing: applicable for pre-marketing submissions including regulatory due diligence and regulatory strategy design. Full service submissions outsourcing: suitable for marketing authorization applications through CP/DCP/MRP/NS and post-marketing authorization maintenance including variations, renewals and notifications. Project based outsourcing: task oriented activity where outsourcing is limited to specific tasks including update of spc & pil information and label artworks, review of promotional materials, pricing and reimbursement, eCTD preparation and publishing. Staff augmentation outsourcing: expand current capacity to meet short or long term business needs.