Regulatory Affairs
Our services include preparing and submitting dossiers, advising on regulatory compliance, product life-cycle management, post approval changes and renewals submission and management.
Pharmacovigilance
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.
Storage & Distribution Consultation
Our services include premise inspection and registration, quality system developments for storage and distribution, compliance audit for storage and distribution and temperature mapping.
Alcare Consultancy
Every year, pharmaceutical and consumer product companies lose months — and hundreds of thousands of dollars — to regulatory delays, rejected applications, and compliance errors. Alcare Consultancy exists to make sure that never happens to your business.
The Tanzanian regulatory environment is structured, constantly evolving and unforgiving of errors. Companies entering the market for the first time — or managing growing portfolios — face an increasingly complex landscape: multiple dossier formats, authority-specific requirements, post-approval obligations and pharmacovigilance duties that carry real legal risk if mismanaged.
Alcare Consultancy exists to take that burden off your desk entirely. We act as your local regulatory intelligence unit — anticipating requirements, preparing compliant submissions and maintaining your market position long after approval is granted.
Alcare Services
Whether you are a foreign manufacturer entering Tanzania for the first time, a local distributor managing a growing product portfolio, or a startup navigating food and cosmetics regulations — we have a dedicated service pathway designed around your specific situation.
Regulatory Affairs
We manage the end-to-end regulatory lifecycle of your pharmaceutical, medical device, food, or cosmetics product in Tanzania and across East Africa. From pre-submission strategy and dossier preparation in CTD or eCTD format through to submission, to authority interactions, post-approval changes, and renewal management — we handle every step so your team can focus on your business
Pharmacovigilance
We serve as your appointed Qualified Person for Pharmacovigilance (QPPV) and/or Local Person for Pharmacovigilance (LPPV) in Tanzania, fulfilling all statutory obligations. Our services cover adverse event monitoring, signal detection, PSUR/PBRER submission, risk management planning and regulatory inspection readiness — ensuring your products remain on the market safely and in compliance.
Storage & Distribution
We guide you on Good Distribution Practice (GDP) and Good Storage Practice (GSP) compliance for warehouses and distribution facilities. Services include premise inspection readiness, GDP quality system development, compliance audits, temperature mapping studies, and registration of storage premises with TMDA/TBS - ensuring your storage and distribution operations meet every regulatory requirements
Three engagement models. One standard of Excellence.
Agent Service
Acting as your Local Technical Representative in Tanzania, we fulfil all obligations of a local agent under TMDA regulations — receiving official correspondence, liaising with the authority on your behalf and ensuring full compliance as your in-country presence. Designed for overseas Marketing Authorisation Holders, manufacturers and suppliers placing products on the Tanzanian market for the first time
Outsourced regulatory Services
Your dedicated regulatory affairs department, without the overhead. We manage all RA activities end-to-end for local distributors: dossier management, authority correspondence, renewals, variations and compliance monitoring — with regular structured updates so you always know where every product stands. Built for long-term partnerships.
Project based regulatory services
Focused, time-bound delivery for specific registration milestones. We assemble the right expertise for your project, deliver to a clear scope and timeline, and provide professional advisory support throughout. Ideal for companies needing expert resource for a defined product launch or market-entry project.
All engagements are available on either a retainer or project fee basis. Contact us to discuss the right model for your situation
Alcare Values
To deliver top-tier consultancy services that ensure our clients' medical and consumer products comply with regulatory standards, fostering public health and safety while supporting the growth of the healthcare and consumer goods industries.
Integrity
Professionalism
Customer Centric
Collaboration
Result-Driven
Expertise
Testimonials
Alcare Consultancy has successfully assisted numerous clients in the pharmaceutical, medical device, food, and cosmetics industries. Our portfolio includes:
We have partnered with numerous reputable organizations, including
Latest Insights
To deliver top-tier consultancy services that ensure our clients' medical and consumer products comply with regulatory standards, fostering public health and safety while supporting the growth of the healthcare and consumer goods industries.
