Depending on the regulatory requirements for each country, the following services are provided:
- Assessment of data required for development and registration of pharmaceuticals / complementary medicines and medical devices for Southern and Sub-Saharan African regions (English speaking). Where national requirements require, collaboration with local independent professionals for submission of dossiers.
- Submission of amendments and labelling changes.
- Regulatory project management to complement in-house regulatory departments in areas such as
- preparation of major submissions.
- development and/or updating of Standard Operating Procedures (SOPs).
- Electronic copies of all correspondence with the regulatory authorities is provided throughout the process to ensure a comprehensive dossier is available in-house at all times.
DRConsulting will work closely with your in-house regulatory affairs team to compile registration dossiers of the highest quality to facilitate approvals in the fastest possible times.