Regulatory Affairs
We manage the full product registration lifecycle—from dossier preparation to authority submissions—ensuring faster approvals and fewer rejections.
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Pharmacovigilance
We help you meet post-marketing safety obligations through structured pharmacovigilance systems, reporting, and risk management.
Storage & Distribution Consultation
We ensure your warehousing and distribution operations comply with Good Storage and Distribution Practices (GSDP/GDP).
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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.
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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
If your product is not registered with TMDA, it cannot legally enter the Tanzania market. Regulatory Affairs is the process of getting that approval — and keeping it. We manage the entire journey: from compiling your technical dossier to receiving your marketing authorisation and managing every post-approval obligation after that.
Our process
Step 1: Initial Assessment — We review your product and determine the correct registration pathway.
Step 2: Dossier Compilation — We prepare and review all technical documentation.
Step 3: TMDA Submission — We submit on your behalf and manage all correspondence.
Step 4: Approval & Post-Market — We handle variations, renewals, and ongoing compliance.
This service is for:
(a) International manufacturers or MAH holders seeking to enter the Tanzania market,
(b) Local distributors managing registrations across a product portfolio,
(c) Companies with lapsed or expiring registrations needing renewals management.
Pharmacovigilance
TMDA regulations require every Marketing Authorisation Holder to have a qualified pharmacovigilance system in place — and a designated person responsible for it. Without this, you face compliance penalties, possible product suspension, and reputational risk. Alcare Consultancy provides that qualified person — and the entire pharmacovigilance system — so you remain compliant without the cost of a full-time in-house hire.
What this means for you: You get a fully qualified QPPV or LPPV on your team — at a fraction of the cost of a full-time employee — who handles adverse event monitoring, regulatory reporting, and all PV system documentation. You stay compliant. We handle the complexity.
Storage & Distribution
A failed TMDA premises inspection or GDP audit can halt your distribution operation and put your entire product portfolio at risk. Alcare Consultancy prepares your storage and distribution operation to pass inspection first time — and maintains your compliance through ongoing audit support and quality system management.
After working with Alcare, your storage facility will be TMDA-registered, your quality systems documented and operational, your staff trained to GDP standards, and your temperature mapping complete — so you are inspection-ready at any time.
Mode of Service Delivery
At Alcare Consultancy, we employ a client-centered approach, offering personalized services tailored to each client’s specific needs. Our team engages in thorough assessments to develop effective strategies and ensure successful outcomes.
Agent Service
Outsourced regulatory Services
We offer outsourced regulatory services for local clients who are distributors of the product within the country. By handling all their regulatory affairs-related activities while maintaining a good relationship through planned and regular updates of the progress. This gives our client time to focus on marketing and distribution of the products. This is meant to be a long term business relationship
Project based regulatory services
We offer project-specific related activities for the marketing authorization of the products. Of which we work professionally to deliver that product into the market. We offer other consultative advice related to the project. It is meant for short-term relationships focused on the delivery of task-related activities.
Clients can choose from project-based or retainer-based arrangements to suit their business needs.
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
Alcare Team
At Alcare Consultancy, we pride ourselves on a team of highly skilled professionals with diverse expertise in regulatory affairs, pharmacovigilance, and quality management. Our multidisciplinary team ensures that we provide comprehensive support across all areas of regulatory compliance.
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.
