Mandi Krebs primarily focuses on regulatory, compliance and commercial matters in the life sciences and health care sectors.
She advises various multinational companies in the pharmaceutical and medical device industries on legal and regulatory matters, including marketing authorisations, licensing, product labelling, advertising and marketing activities as well as pricing and reimbursement matters in South Africa.
In addition, Mandi advises multinational pharmaceutical companies regarding market entry into various jurisdictions across Africa.
Mandi has valuable experience in advising clients in the medical device industry on matters related to interactions with health care professionals and patients, reimbursement models, and challenging competitor's claims.
Her general experience includes negotiating and drafting of commercial agreements, due diligence investigations and providing general legal advice. In particular she advises clients on a wide range of commercial contractual arrangements, including consultancy, sponsorship, co-promotion, collaboration, manufacturing and distribution services.
Mandi is very experienced in liaising with enforcement authorities and regulatory bodies in South Africa and across Africa.
- Preparation of tenders and pitches, and negotiating contracts and subcontracts involving issues such as the supply and manufacture of medicines, complementary medicines and medical
- Advising on local market entry, market authorisations, licensing of entities, as well as the registration of medicines, complementary medicines and medical devices.
- Assisting with the acquisition and disposal of life sciences companies and businesses, including the implementation of joint ventures.
- Drafting and vetting of complex commercial agreements, including licensing agreements, distribution and warehousing agreements, as well as agreements relating to contract manufacturing.
- Providing advice relating to the labelling and advertising of medicines, complementary medicines, medical devices, food stuffs, cosmetics and chemicals.
- Advising on all aspects of M&A transactions.
- Providing multinational pharmaceutical entities with regulatory advice including the imposition of data fees, marketing activities, importation of medicines and medical devices and licensing applications.
- Conducting compliance audits on behalf of clients in the health care and pharmaceutical industries, and advising on adherence to regulatory guidelines.
- Advising one of South Africa’s largest medical aid schemes in relation to the provision of clinical services to its beneficiaries.