Regulatory, Importation and Public Procurement Consultant at Sight and Life

Issued by: Sight and Life Foundation
Country: Tanzania
Engagement Model: Tanzania-based individual consultant, consultancy firm or consortium with demonstrated Tanzania regulatory and procurement expertise
Assignment: Aug 2026 – October 2028 (delivery-based)
Location: Tanzania, primarily remote, with in-country meetings and travel as required

Background

Sight and Life Foundation is working in multiple countries to improve sustainable access to quality-assured UNIMMAP Multiple Micronutrient Supplements (MMS) for pregnant women in low- and middle-income countries. Against this background, SAL seeks an experienced Tanzania-based regulatory and public procurement consultant, consultancy firm or consortium to assess and navigate the full pathway from product selection to lawful registration, importation and eligibility for federal and, where relevant, state-level government procurement.

2. Purpose of the Assignment

The purpose of the assignment is to provide end-to-end regulatory, importation and public-sector market-access support for UNIMMAP MMS in Tanzania. The consultant, consultancy firm or consortium will produce an evidence-based assessment for Tanzania, develop and execute a product-specific registration strategy, support regulatory submission and review, and document the conditions required for government procurement eligibility and sustainable supply.

3. Objectives

• Determine the legally supportable classification and regulatory pathway for the exact MMS product and presentation proposed for Tanzania.
• Identify all regulatory, technical, documentary, site, laboratory, labeling, import, customs, tariff, tax, and local-representation requirements.
• Establish the policy, formulary, product-coding, supplier-registration, procurement and financing requirements that must be met before the product can be lawfully purchased by the government.
• Develop a costed, dependency-based Tanzania roadmap from initial assessment through registration, first import and government procurement readiness.
• Support preparation, submission and management of the product-registration application, including samples, inspections, testing, queries, and variations.
• Assess and support the selection of competent and ethical local MAHs, regulatory representatives, importers and distributors, where required.
• Capture actual timelines, costs, barriers, waivers, precedents and lessons to strengthen the Tanzania regulatory roadmap.

3. Country Scope and Operating Principles

4.1 Country Scope: Tanzania
4.2 Product and Supply Routes
4.3 Evidence and Validation Standard

5. Scope of Work

5.1 Inception, Product Definition, and Stakeholder Mapping
5.2 Regulatory Framework, Governance and reliance
5.3 Product Classification, Claims, and National Policy Alignment
5.4 Registration Strategy and Dossier Gap Assessment
5.5 GMP, Site inspection, Samples, and Laboratory Testing
5.6 Submission and Regulatory Process Management
5.7 Importation, Customs, Tariff, and Tax assessment
5.8 Government Procurement and Public-Sector Market Access
5.9 Sub-National Procurement, Distribution, and Supply-System Readiness
5.10 Local MAH, Regulatory Agent, Importer, and Distributor Due Diligence

6. Expected Deliverables and Acceptance Criteria

All deliverables under this TOR relate to Tanzania. D0: Inception Package, D1: Tanzanian regulatory, importation and procurement assessment, D2 - Tanzania registration and market-access strategy, D3 - Local MAH/importer/distributor due diligence and contracting support, D4 - Submission-ready dossier and sample package, D5 - Formal submission and regulatory process management, D6 - Regulatory decision and public-sector market-access close-out, D7 - Final Tanzania report and knowledge products.

6.1 Suggested Payment Linkage

The final contract may link payments to acceptance of deliverables rather than elapsed time. D0 inception package, D1 assessment and evidence pack, D2 strategy and roadmap, D3 local-partner due diligence, D4 submission-ready dossier, D5 submission and process management, D6–D7 close-out and knowledge products

7. Required Methodology

• Structured desk review using current official sources and archived copies of all cited materials.
• Key-informant interviews and formal consultations with relevant authorities, government buyers, central medical stores and other stakeholders.
• Completion of the project questionnaire and evidence checklist, including status of each response and unresolved clarification.
• Triangulation of legal requirements with recent comparable applications, tenders, imports and actual administrative practice.
• Written confirmation for high-risk or ambiguous matters, especially classification, CoPP/FSC acceptability, foreign GMP inspection, tariff code, exemption, registration timing for tenders and government procurement eligibility.
• Version-controlled trackers for questions, documents, decisions, costs, timelines, submissions, correspondence, risks and actions.
• Strict separation of official fees, legitimate third-party costs and consultant professional fees. The consultant, consultancy firm or consortium must not propose, facilitate or reimburse improper payments.

7. Reporting, Governance and Working Arrangements

8.1 Reporting cadence

• Biweekly written status update and Immediate written notification of any issue.
• Monthly steering call with Sight and Life and the manufacturer, with a current decision log, risk register and action tracker.
• Formal meeting minutes within three business days of material authority or government meetings.

1. Duration, Level of Effort and Travel

The anticipated assignment period is Aug 2026 to October 2028. The engagement is deliverable-based and the level of effort will depend on Tanzania’s classification decision, application pathway, inspection and testing requirements and regulatory-review progress. The consultant, consultancy firm or consortium should be available for remote work and meetings within Tanzania.

10. Consultant / Firm Qualifications

• At least 10 years of relevant experience in regulatory affairs, pharmaceutical or nutrition-product registration, public procurement, importation or health-commodity market access in Tanzania.
• Demonstrated success with product registration and regulatory submissions for medicines, vitamin/mineral products, food supplements, nutraceuticals or comparable oral solid dosage forms.
• Strong working knowledge of TMDA, applicable dossier formats, GMP expectations, laboratory and sample processes, import permits and post-approval requirements in Tanzania.
• Demonstrated knowledge of Tanzania’s public procurement framework, supplier registration, e-procurement, federal and state procurement, medical-store systems, international competitive bidding and government health-commodity contracts.
• Ability to analyze Tanzanian customs classification, import documentation, tariff, VAT and exemption questions in coordination with competent customs and tax specialists.
• Experience conducting due diligence on Tanzanian MAHs, importers and distributors, including licensing, beneficial ownership, debarment, conflicts and operational risk.
• Excellent analytical, project-management, writing, documentation and stakeholder-engagement skills in English; ability to work effectively with federal and state stakeholders in Tanzania.

10.1 Desirable qualifications

• Experience with UNIMMAP MMS, prenatal vitamins, essential medicines or maternal and child health commodities.
• Familiarity with UNICEF procurement/quality requirements, WHO reliance mechanisms, regional harmonization and donor-financed procurement.
• A multidisciplinary team combining regulatory, quality/GMP, public procurement, customs/tax and legal expertise.
• Experience producing Tanzania regulatory roadmaps, implementation toolkits and training materials for manufacturers or government agencies.

1. Proposal Submission Requirements

• Technical proposal explaining the Tanzania-specific methodology, workstreams, authority-engagement approach, evidence standards and quality assurance.
• Detailed workplan and critical-path schedule, clearly distinguishing the assessment, dossier-preparation, submission and post-submission phases.
• Team structure, CVs, allocation of roles, presence and operational capacity in Tanzania, and availability of key personnel.
• At least three examples of comparable assignments in Tanzania, or highly relevant ECOWAS markets where Tanzania experience is supplemented by a strong Tanzanian team, including product category, scope, outcome and client reference where permitted.
• Disclosure of current or recent representation of competing MMS, IFA or prenatal-supplement manufacturers; government employment/consultancy; and any other actual or potential conflict of interest.
• Financial proposal showing professional fees by deliverable and role, official fees, estimated third-party expenses, travel assumptions, taxes and currency. Official government fees must not be marked up.
• Confirmation of willingness to comply with Sight and Life’s confidentiality, data protection, anti-bribery, sanctions, safeguarding and intellectual-property requirements.

1. Indicative Evaluation Criteria

Bangladesh regulatory and registration expertise, Bangladesh government procurement and public-sector market-access expertise, technical methodology, evidence plan and understanding of the assignment, Relevant team composition, availability and project management, Comparable experience and references, financial proposal and value for money.

Contact Person: Zainab Abubakar - Project Lead

Email: [email protected]
Deadline for submission of Proposal: 31st of August 2026

NB: For interested and qualified parties please kindly send an email to the contact person for a more detailed TOR