New Product Registrations
Streamlined and Fully Compliant Product Entry
Getting a new pharmaceutical product approved doesn’t have to be slow or stressful. We manage the entire registration process with the Tanzania Medicines and Medical Devices Authority (TMDA) and other relevant bodies, ensuring every submission meets the highest standards of quality and compliance.
Our services include:
- Thorough technical file review and gap analysis
- Preparation and electronic submission of complete dossiers (CTD/eCTD format when required)
- Proactive query reply management and liaison with authorities
- Regular follow-ups with real-time status updates and strategic advice
With our proven process, your products reach the market faster, with minimal revisions and zero surprises.
New Premise and Site Registrations
Establish Operations with Confidence and Compliance
Opening or upgrading a pharmaceutical manufacturing facility, warehouse, or distribution center requires flawless regulatory alignment. We guide you through the entire site registration and Good Manufacturing Practice (GMP) certification journey. Key support areas: Preparation and submission of site registration dossiers Pre-inspection coordination and mock audits Corrective and Preventive Action (CAPA) planning, review, and submission Continuous follow-up until final approval and licensing Our goal: audit-ready premises that pass TMDA inspections on the first attempt, allowing you to start operations quickly and confidently.
Post Registration Services
Ongoing Compliance to Protect Your Market Presence
Regulatory obligations don’t end with approval. We help you maintain full compliance throughout the product lifecycle so your medicines and devices remain legally marketable without interruption.
Services include:
- Timely re-registration and renewal applications
- Management of all types of variations (major, minor, and administrative changes)
- Processing of import and export permits
- Lifecycle management strategy and regulatory intelligence updates
Stay ahead of renewals and changes with proactive support that keeps your portfolio active and compliant year after year.
Specialized Pharmaceutical Support
Tailored Solutions Beyond Standard Registration
We offer a wide range of additional services designed to address the unique challenges faced by pharmaceutical businesses in Tanzania and across East Africa. These include: Local Authorized Person and Qualified Person for Pharmacovigilance (QPPV) representation Customized staff training programs on regulatory affairs, GMP, GDP, and pharmacovigilance Business consulting for market entry strategy, partnership structuring, and expansion planning Regulatory due diligence for mergers, acquisitions, or product portfolio transfers Pharmacovigilance system setup and ongoing safety monitoring Whatever stage your business is at — startup, scale-up, or established player — we deliver flexible, expert support that aligns with your specific objectives.