Our regulatory affairs consultants will help to create and design innovative regulatory strategies, aimed at getting product approval in the shortest possible time
Preparation of dossiers for health authorities as per current guidelines & ensure that all complies with latest regulations
Preparation and review of regulatory submissions, including:
New drug application (NDA)
Marketing authorization application (MAA)
Due diligence of the product to assure it can be applied for registration in the ME region e.g
Preparation, review & translation of the artworks text to match the requirements of the authorities and provide you with ready to print files
Preparation & collection of the information required for the product pricing at the authority using our up to date database
Support for the registration of your manufacturing site/company at the authority and help in maintaining the license renewal across the region
Support submission of the registration files providing direct interactions and negotiations with the authority
Post submission: following up & handling of any queries that might be raised by the authority and respond to it quickly & efficiently to facilitate the review of applications, maximizing the probability of a successful and speedy outcome
Post registration: we will support the maintenance and Life Cycle Management of products, with support to variations, line extensions, renewals and PSUR submission.
Pharmacovigilance reporting and management
Medical Training / updates to FF
Medical information handling
Coordination of medical information with Partner Medical Affairs
Work with KOLs to ensure presentation content is in line with product official use
Screening of new marketing and promotional material making sure it meets regulatory and product requirements coordination for approval by RA
support obtaining required approvals for promotional materials
