TOR EU/UK Regulatory Compliance firms

Terms of Reference (TOR)Consultancy for EU Biocidal Testing Requirements and Cost AnalysisIssued by:YBMS Biotec LtdTrinidad and TobagoDate: 21 July 20251. BackgroundYBMS Biotec Ltd is a Trinidad and Tobago–based manufacturer of environmentally responsible disinfection and sterilization solutions. Our flagship product, BIOTECplus, is a broad-spectrum, non-toxic, biodegradable biocidal formulation used across medical, agricultural, veterinary, and food-processing sectors.As part of our export expansion strategy, we are preparing to enter the EU market and require detailed guidance on testing requirements necessary for biocidal compliance under the EU Biocidal Products Regulation (EU BPR 528/2012).2. ObjectiveTo engage a qualified UK or European regulatory consulting firm, if EU preferably based in the Netherlands, to:Identify all testing and data requirements applicable to BIOTECplus under EU/ UK BPR,Provide cost estimates for completing required testing through EU-recognized GLP laboratories, andRecommend suitable OECD GLP-accredited laboratories in the EU to conduct efficacy, toxicology, and ecotoxicology studies.3. Scope of WorkThe consultancy will focus on:Testing Requirement AssessmentIdentify the mandatory test categories under EU BPR (e.g., efficacy, acute toxicity, ecotoxicity, skin/eye irritation, biodegradability, etc.) relevant to BIOTECplus’s product type(s).Determine which existing international certifications (ASTM, EPA, or TTBS) may satisfy or partially fulfill these requirements.Laboratory Identification & CostingProvide a comparative overview of EU GLP-certified laboratories (preferably in the Netherlands, Germany, and France).Gather estimated testing costs, timelines, and test protocols from at least three laboratories for each required test.Compliance Pathway & RecommendationsSummarize the step-by-step process for achieving BPR-recognized test validation.Outline estimated total costs, timelines, and potential efficiencies (e.g., mutual recognition of tests).4. DeliverablesA concise Testing Requirements Matrix outlining all EU-mandated tests for BIOTECplus.A Cost Analysis Report summarizing laboratory options, pricing, and timelines.A Compliance Roadmap detailing next steps for progressing to formal EU BPR submission readiness.5. DurationThe consultancy is expected to be completed within 6–8 weeks from the date of engagement.6. Evaluation CriteriaPreference will be given to firms that:Are based in the Netherlands or the wider EU with regulatory experience in biocidal product testing.Have existing relationships with EU GLP-accredited laboratories and familiarity with the product registration process for all EU and UK territories ( international regulatory knowledge is also an asset).Can demonstrate a proven track record in pre-market regulatory and testing advisory for biocidal disinfectant products.7. Submission RequirementsInterested firms are invited to submit:Company profile and relevant EU BPR experience.Proposed methodology and timeline.Estimated consultancy cost (excluding laboratory fees).Sample of similar previous work, if available.8. Submission DeadlineAll proposals should be submitted electronically to: 📩 sales@ybmsbiotec.com no later than 1st November 2025.