Drug safety or Devices safety monitoring is a global trend in today’s world, and it is the responsibility of the Marketing authorization holder to design, establish and implement Pharmacovigilance System as part of the risk management plan of product use in the market. We offer comprehensive pharmacovigilance services to ensure the safe and effective use of medicines and medical devices. We offer these services by acting as Qualified Personnel for Pharmacovigilance (QPPV) and/or Local Person for Pharmacovigilance (LPPV), thereby handling all responsibilities stipulated by regulation and guidelines for QPPV.

Alcare Consultancy provides guidance on Good Distribution Practices (GDP) and Good Storage Practices (GSP) for medical and consumer products, ensuring that your products are handled, stored, and distributed according to international standards. Our services include premise inspection and registration, quality system developments for storage and distribution, compliance audit for storage and distribution and temperature mapping.

We assist companies in navigating the complex regulatory landscape for the registration of medical products (medicines and medical devices) and consumer products (foods and cosmetics) with local regulatory bodies such as the Tanzania Medicines and Medical Devices Authority (TMDA) and Tanzania Buareu of Standards (TBS). Our services include preparing and submitting dossiers, advising on regulatory compliance, product life-cycle management, post approval changes and renewals submission and management.