WHO WE ARE
KD Consulting (KDC) is a specialised pharmaceutical consulting practice delivering regulatory affairs, quality assurance, risk management, pharmacovigilance and compliance services and solutions, through a robust scientific approach, being backed by over a decade of consulting experience in Africa and professional service delivery.
KDC was founded by Dineshree Naiker and Kacy Rajappen in 2007 following approximately ten years each in key senior executive roles in multinational pharmaceutical companies operating in South Africa.
The business of KDC was set up based on the reputations and track record of both founding members within the pharmaceutical industry, but the business’ success and growth to date is entirely attributed to the KDC team with their shared value of integrity, a passion for meaningful contribution to healthcare, use of sound science as the basis of all projects and conscientious delivery of quality and consistency of work to global scientific standards.
The KD Consulting team at present is made up of five full time members, providing scientific technical support in the fields of Regulatory Affairs and Quality Assurance, supported by general administrative, finance and IT team members.
Our history of Consulting
Since 2007, KDC have engaged with a broad spectrum of pharmaceutical and related healthcare companies in support of their regulatory activities by assisting with new product dossier due diligence, creation of a South African tailored and scientifically reviewed application and the filing of such application to the South African Health Products Regulatory Authority (SAHPRA) or other National Regulatory Authority (NRA) in Southern Africa. In addition, this service is complemented by similar services for on-going variation submissions as part of dossier compliance and maintenance, as well as supported by the provision of strategic advice on regulatory and market access in the region.
KDC is extremely well versed in a cross-spectrum of all regulatory types of submission across all therapeutic areas. Servicing a host of multinational and South African national pharmaceutical companies with regulatory submissions for new chemical entities, biological medicines, generic medicines, combination medical devices, veterinary medicines, complementary medicines, stock remedies and nutritional feed supplements, in South Africa and in the SADC region.
Notably, KDC was involved at the outset in one of the only two CTD submissions when first introduced in South Africa in 2009 as the very first CTD submissions to SAHPRA ever. Since then, KDC have been actively involved in a multitude of eCTD and e-Submission filings to date. A significant success for KDC in 2020, has been the successful SAHPRA licencing of a new medicine, making use of innovative regulatory strategy, in a total registration time of 14 months from filing to approval date with SAHPRA - an unprecedented registration timeline in itself, but more-so in the midst of COVID-related delays, combined with no expedited-review requirement.
KDC is proud of its impact and contribution to society by way of meaningful involvement with novel R&D companies, innovative medicine developers, not-for-profit organisations and healthcare-activists in civil society fostering registration and access to medicines within key therapeutic areas of focus for South Africa as well as Southern Africa.
WORKING IN SOUTHERN AFRICA
More recently, KDC has gained extensive exposure and experience with WHO Dossier Prequalification, an exceptionally valuable tool for medicine registration and access in Southern Africa, as well as initiating and progressing applications for registration through the harmonised platform of the African Medicines Regulatory Harmonisation (AMRH), and in particular the ZAZIBONA process, for the broader SADC region with extremely positive results.
Active involvement in current affairs & new developments
In today’s competitive environment, reducing time to market is key to the success of product and company alike. KDC uses its expertise to further your advantage as and when you need it, and in addition, offers you an optional solution for easy commercial access to the South African and neighbouring markets.