Partnering for Success
There has been a shift over the last five years towards strategic partnerships.
Registration of dossiers
All new drugs and medical devices require registration with SAHPRA.
Crux submits dossiers as applicant for and on behalf of companies who do not have the pharmaco-legal capacity and facilitates the process from start to finish this includes:
deliverable gap analysis report of data
package inserts and patient information leaflets (SmPc)
advertising compliance, screening of promotional material
All pharmaceutical manufacturers are required to have a site master file (SMF).
This contains specific information about
the quality management policies and activities of the site,
production and/or quality control of pharmaceutical manufacturing operations
carried out at the named site,
and any tightly integrated operations at adjacent and nearby buildings.
The SMF provides clear information on the manufacturer’s good manufacturing practices (GMP)-related activities that can be useful in general supervision and in the efficient planning and undertaking of GMP inspections