Partnering for Success
Pharmaceutical Services
There has been a shift over the last five years towards strategic partnerships.
Registration of dossiers
All new health products and medical devices require registration with SAHPRA before it may be sold in South Africa.
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:
Review of regulatory information with a
deliverable gap analysis report of data
Development of
labels, package inserts and patient information leaflets (SmPc)
Management of the registration dossier life cycle, from first submission to various variation type submissions including transfer of applicancy.
Adherence to the Medicine Act 101 of 1965, Regulations and Marketing Code –
Advertising compliance, screening of promotional material and training on the code
Site Establishment
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, auditing of laboratories and manufacturers.