Services

Project Management

Short- to medium term projects in the pharmaceutical industry. These include, but are not limited to:

Research and development of marketing strategies (including initial product research, development of detail aids, compilation and translation of verbal selling points, etc.) in close collaboration with the marketing team of the client company

Ensure that all marketing material is medically correct and that it complies with the Medicines Act (101 of 1965) and Marketing Code of Conduct in terms of advertising of medicines

Package Inserts and Patient Information Leaflets (with Afrikaans translation, where applicable):

Design package inserts and patient information leaflets for new chemical entities as well as generic multisource medicines and ensuring that these comply with current legislation
Design package inserts and patient information leaflets for complementary and alternative medicines (CAMs) and ensuring that these comply with current legislation
Design package inserts and patient information leaflets for medical devices and ensuring that these comply with current legislation

Bioequivalence study reviews
Clinical motivations in support of product registration with SAHPRA (South African Health Products Regulatory Authority)

Clinical policy and funding guideline construction using Evidence Based Medicine principles
Review of existing policies and funding recommendations
Development of Standard Operating Procedures
Training of managed healthcare personnel
Development of treatment algorithms to ensure compliance with Prescribed Minimum Benefits

Development of research protocols for clinical research involving human subjects
Development of case record forms
Development of patient leaflets and informed consent documents
Development of principal investigator brochures
Above services include Afrikaans translation, where required