REQUEST FOR EXPRESSION OF INTEREST

Assignment Title:Individual Consultant Services for Preparation, Establishment, and Training in Good Manufacturing Practices (GMP) and Product Registration

Reference Number AGROPY/CONS/2026/001

Method: Individual Consultants Selection.

1.1. Background.

AgroPy Ltd is a Rwanda-based fformulator & manufacturer of organic and Eco-friendly Products applied in Agriculture, Veterinary and Public Health Pest Control including mosquito control . Our key botanical insecticide active: Pyrethrum Pale Extract, contains pyrethrins that are extracted from Pyrethrum flowers grown by local farmers and processed locally. We operate an Integreted Management System (IMS) which complies with three management Systems’requirements namely; ISO 9001, ISO 45001 and ISO 14001. 

1.2 Source of Funds

 This consultancy will be financed through AgroPy Ltd internal funds.

1.3 Rationale for the activity.

AgroPy Ltd is working towards getting regulatory approval or certification (GMP Certificate & Product registration Certificate) for their products in Rwanda and in the region's national regulatory agencies (NRAs). In this regard, product certification is one of the key area of focus to ensure that AgroPy Ltd produce high-quality, guaranteed products in full compliance with local, national, and/or international regulations and standards.Additionally, as the agency starts to enforce requirements ensure compliance of manufactured products, such as requiring and reviewing data, training is needed for staff on evaluating of data submitted in dossiers at Rwanda FDA and other foreign NRAs .

1.4 Expected Results.

Conduct a systematic assessment to determine whether AgroPy Ltd comply with quality system and current Good Manufacturing Practices (cGMP) to ensure regulatory compliance and certification readiness.The expected result of this activity will be the GMP Certificate.

Dossier Compilation, Compile registration documents as per regulatory standards for products manufactured by AgroPy Ltd for submission at Rwanda FDA and other Regulatory bodies where AgroPy Ltd would want to market their products. 

Assess existing dossiers information in terms of compliance with legislative requirements identifying gaps necessitating updating before submission, that assist in overcoming irrelevant queries as to reduce long periods of registration.

 Develop missing required documentation for all manufacturing processes and Integreted Management System (IMS). Also review the existing documents to identify the missing content.

Conduct training on GMP requirements and on the developed documents for AgroPy Ltd staff to increase their knowledge and understanding for regulatory compliance.

1.4 Methodology.

We will begin with identifying experienced experts in regulatory affairs with good knowledge of developing required documentation for production processes, Dossier Compilation for product registration and current Good Manufacturing Practices (cGMP) to ensure regulatory compliance and certification readiness. 

Work hand-in-hand with the identified experts from the beginning to obtain the most accurate data and information to support execution of our vision. Collaborate with with the identified expert at each step of the way and build in regular checkpoints to ensure your satisfaction. 

We will aim at strengthening the capacity of staff in the areas of cGMP requirements and Dossier Compilation. This will be achieved by building the capacity of staff to be equipped with knowledge and skills to understand GMP requirements, Dossier Compilation and all developed documents for all manufacturing areas. Also align the processes to local and international regulatory standards. 

1.5 Conflict of Interest

The consultant shall disclose any actual or potential conflict of interest that may affect the assignment.

1.6 Confidentiality

All information obtained during the assignment shall be treated as strictly confidential and shall not be disclosed without prior written consent from AgroPy Ltd.

1.7 Payment Terms

Payments shall be made based on deliverables as follows:

• 20% upon approval of inception report
• 40% upon submission of assessment and documentation to FDA after approval
• 40% upon submission of final deliverables and training and receiving certificate completion 

Final payment should be done after providing completed report regarding on terms of reference and activities have been completed 

1.8 Type of Contract

This will be a Lump Sum Consultancy Contract.

1.9 Taxes 

The consultant shall be responsible for all applicable taxes in accordance with Rwanda laws.

TERMS OF REFERENCE (ToR)

01. Background and rationale 

AgroPy Ltd (formerly Agropharm Africa Ltd) is the only manufacturer of organic and eco-friendly pesticides in Rwanda. AgroPy manufactures products for use in the agricultural, horticultural, veterinary and public health pest control sectors including mosquito control. Our key botanical insecticide active: Pyrethrum Pale Extract, contains pyrethrins that are extracted from Pyrethrum flowers grown by local farmers and processed locally. Several thousand farmers from the Northern Province depend on Pyrethrum growing for household income.

AgroPy Ltd is working towards getting regulatory approval or certification for their products in Rwanda and in the region's national regulatory agencies (NRAs). In thisregard, product certification is one of the key area of focus to ensure that AgroPy Ltd produce high-quality, guaranteed products in full compliance with local, national, and/or international regulations and standards.Additionally, as the agency starts to enforce requirements to ensure compliance of manufactured products, such as requiring and reviewing data, training is needed for staff on evaluating of data submitted in dossiers at Rwanda FDA.

02. Scope of the assignment /responsibilities of the consultant.

• Outline processes and steps to follow while conducting a systematic assessment of the organization to determine whether the manufacturer comply with quality system and current Good Manufacturing Practices (cGMP) to ensure regulatory compliance and certification readiness.
• Dossier Compilation, Compile registration documents as per regulatory standards for products manufactured by AgroPy Ltd for submission at Rwanda FDA and other Regulatory bodies where AgroPy Ltd would want to market their products. 
• Assess existing dossier information in terms of compliance with legislative requirements identifying gaps necessitating updating before submission, that assist in overcoming irrelevant queries as to reduce long periods of registration.
•  List all required documentation required by a manufacturing to comply with regulatory requirements.
• Develop missing required documentation for all manufacturing processes. 
• Review the existing documents to identify the missing content and align to regulatory requirements.
• Conduct training on GMP requirements and on the developed documents for AgroPy Ltd staff to increase their knowledge and understanding for regulatory compliance.

03. Duration of the consultancy 

This assignment will be for 12 months to take place from the date of the contract signing. 

04. Duty station.

Consultant to work both remotely and on site. Travel to the venue (Musanze) for days that require onsite activities. Deliverables may be submitted electronically. 

Closing the non-conformities from the inspections and accampagning the AgroPy Ltd up to GMP certification.

05. Deliverables 

The consultant will be expected to provide the following deliverables electronically: 

1. a) Inception report outlining the process for the asignment that demonstrates how the consultant will deliver on the scope of work
2. b) Systematic assessment report of the organization to identify the gaps related to regulatory compliance and certification readiness
3. C) Reviewed dossiers with comments for product registration as per regulatory standards for products manufactured by AgroPy Ltd for submission at Rwanda FDA and other Regulatory bodies where AgroPy Ltd would want to market their products for
4. D) Developed/reviewed documents required by AgroPy Ltd to comply with regulatory requirements.
5. E) GMP training report for AgroPy Ltd staff to increase their knowledge and understanding for regulatory compliance.
6. F) CAPA report responding to Rwanda FDA existing queries.

06. Monitoring and progress control, including reporting requirements, periodicity format and deadline: 

The consultant is required to seek inputs and provide periodic updates to the designated person by AgroPy Ltd. The consultant will be required to participate in meetings required to finalise the assignment. 

07. Supervisory arrangements:

The consultant will contractually work under the supervision of the general supervision of AgroPy Ltd.

08. Qualifications, expirience and skills:

Interested Individuals must meet the following requirements: 

a) Graduate level education (master’s or higher) in regulatory sciences. 

b) At least ten years of experience of working at a National Regulatory body as GMP inspector and dossier assessment for product registration. 

c) Previous experience in developing site master file, quality manuals, policies, protocols, SOPs, forms and formats used in manufacturing processes (Related to GMP) 

d) Fluency in English (written and spoken), (French will be an added advantage) 

09. Proposal submission guidelines 

The proposal should demonstrate sound knowledge, technical skills and capability as required by the nature of the work assignment and understanding of the requisite tasks set forth in the scope of the assignment 

Applicants should submit both technical and financial proposals. The financial proposal should quote consultancy fees. 

The technical proposal should have the following sections: 

• Understanding of the assignment 
• methodology to be used in undertaking the assignment 
• performance monitoring and reporting 
• work plan / activity schedule 

Additional Financial Proposal and Proforma Invoice Requirements

The financial proposal shall be submitted in the form of a Proforma Invoice and must clearly indicate the total lump sum cost of the consultancy services. The Proforma Invoice shall include, but not be limited to, the following details:

• Full name and address of the consultant 
• Contact details (email and phone number) 
• Tax Identification Number (TIN) 
• Bank account details for payment 
• Reference number of the assignment (as indicated in this REOI) 
• A clear breakdown of costs linked to deliverables or phases of the assignment 
• Total contract price (lump sum) clearly stated in figures and words 
• Currency of the proposal 
• Validity period of the quotation (minimum 90 days) 
• Signature and date 

The financial proposal shall be inclusive of all applicable costs, including professional fees, travel, accommodation, and any other related expenses. No additional costs shall be accepted beyond the agreed contract amount.

10. Evaluation criteria 

For evaluation of the proposals the following criteria will be applied: 

1. a) General Education Qualifications and Relevant Training (15 points) 
2. b) Relevant Experience Related to the Assignment (25 points) 
3. c) Adequacy and quality of the proposed methodology, and work plan/ activity schedule in responding to the Terms of Reference (TORs) (50 points) 
4. d) Language Proficiency – more than one language (10 points) 

Minimum technical score: 70% Only candidates meeting the minimum score will have their financial proposals evaluated.

11. Ownership of Deliverables

All reports, data, documents, training materials, and any other outputs developed under this assignment shall become the exclusive property of AgroPy Ltd. The consultant shall not use, reproduce, or distribute any part of the deliverables without prior written consent from AgroPy Ltd.

12. Performance and Penalty Clause

The consultant shall perform the assignment in accordance with the agreed timeline and deliverables. Failure to meet agreed milestones without justified cause may result in:

• Application of penalties as per contract terms 
• Withholding of payments linked to incomplete deliverables 
• Termination of the contract in case of continued non-performance

13. Invitation 

AgroPy Ltd invites eligible and qualified individuals to submit their proposals to provide the Services. Electronic submission of the applicant’s resume, application letter, and relevant documentation should be submitted to: procurement@agropyltd.com

Deadline for receipt of proposals is on 12th June 2026 5:00pm local time GMT

For more information contact with +250 788535091/ +250 780370180
 

Done at Musanze, on 2nd June 2026

Deo AGABA
Ag-Managing Director

AgroPy Ltd