Preparation and submission of Marketing Authorisation applications (MAA) in UK, EU, ANZ, MENA, APAC and USA regions.
Assist you through all the regulatory documents requirements and advice on filing strategy to ensure the correct legal basis and most appropriate submission route is used to ensure faster approval.
Marketing Authorisation transfers (change of ownerships) under in licensing and out licensing activities.
Due diligence of dossiers
All Minor/ Major variation applications i.e. CMC, Safety and admin preparation and submission
Product information update variation i.e. SmPC, PIL and Labelling
Site transfer/ addition submission
Renewal application preparation and submission.
Sunset clause exemption applications
Response to RFI preparation and submission.
MIA set up and registration application
WDA set up and registration application
Controlled drug License application
Strategic consultancy during pharmaceutical development and lifecycle management.
CMC scientific and technical writing.
Compilation of quality dossiers (ICH and non-ICH)
CTD modules 3 and 2.3.
CMC maintenance support: change control and quality variations
GxP services (GMP, GACP, GDP) including audits.
Development and maintenance of EU regulatory product information
Preparation of Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and label for marketing authorization applications
Communications with health authorities / agencies
Provision of labeling repository
Tracking and monitoring of status and key milestones
Artwork management
Translation services
Proof-reading and readability testing
Quality control
Assist pharmaceutical organizations to streamline entire Regulatory submissions management process within Microsoft SharePoint regulatory database.
Dossier development, submission planning, tracking, publishing, and final submissions to Health Authorities (HAs) including delivery confirmation/acknowledgement.
As global HAs publishing in electronic format.
Publishing of region-specific formats for all kinds of submissions such as: paper, electronic, eCTD, and NeeS.
Engagement in Companies Merger and Acquisition regulatory activities.
Enter into emerging markets with existing and new products dossiers.
