Bid for the appointment of professional engineering services (design and management) firm for the modification of an existing structure for the establishment of a Radioiodine Active Pharmaceutical Ingredient (API) facility.Closed

Overview

Appointment of a professional engineering services (design and management) firm to modify an existing structure for the establishment of a Radioiodine I-131 API manufacturing facility. Bidders should be ESCA-registered engineering consultancies with radiopharmaceutical/cGMP facility design and project-management experience, able to deliver across design, cost estimation, procurement oversight, and commissioning/qualification (per NTP-SOW-4019 and URS-NTP-SPE-4162/4168).

Requirements

• Proven track record in design, management and commissioning of radiopharmaceutical/facility projects compliant with cGMP and SAHPRA/PIC/S guidelines.
• Ability to deliver across a six-stage ESCA-aligned process with gate reviews, including development of detailed facility design, cost estimates, and C&Q documentation (DQ/IQ/OQ/PQ).
• Competence in integrating facility systems (HVAC, utilities, BMS interfaces) and preparing required traceability (RTM) and regulatory-compliant documentation; exclusion of the hot cell line from scope.
• Knowledge and adherence to NECSA SHEQ requirements and external design organization standards; familiarity with SANS/ISO standards relevant to cleanrooms, safety, and radiological controls.
• Compliance with tax, B-BBEE, and procurement rules (SARS TCS/CSD), and ability to provide required bid documentation (SBD forms, Pricing Schedule, RTM, and relevant declarations).

How to Apply

• Deadline: 16 September 2026 at 09:00 (Closing date/time stated in Tender Metadata; some attached docs list 11:00; verify on portal) (see Main Invitation and SBD attachments).
• Submission method: Online electronic submission via Necsa’s eTender portal (Online esubmission).
• Documents to submit: Official bid forms and pricing schedule (SBD1, SBD3.2, SBD6.1), Pricing Schedule, Tax Compliance requirements (SARS PIN, TCS or CSD number), BBEE documentation, and the Traceability Matrix (RTM) demonstrating compliance to NTP-SPE-4162/4168; include any required resolutions for consortiums.
• Pre-qualifications: Tax clearance or SARS PIN; CSD registration; BBEE verification where applicable.
• Briefing: Non-compulsory site briefing 26 August 2026 at 10:00 (in-person: Pelindaba) or via Microsoft Teams (see Main document for link).
• Where to obtain documents: Bid documents and related files are available online (FIN-SCM-TEN-0246 package; includes SBDs, SOW, URS, and BMS/RTM templates).
• Additional notes: Adhere to NECSA terms and conditions (NECSA Terms & Conditions of Contract) and project-specific URS/RTS requirements attached to the tender.