Eramol | Non Sterile Clinical Facility

https://eramol.com/clinical-services-category/non-sterile-manufacturing/Eramol Non-Sterile ManufacturingGMP Production of Tablets, Capsules & Oral Liquids for Phase I–III and Commercial SupplyEramol delivers end-to-end non-sterile manufacturing built on a foundation of quality, regulatory expertise and Qualified Person (QP) leadership.Our Sevenoaks GMP facility, commissioned in November 2021 and operational since August 2022, supports the full product lifecycle—from early-phase clinical development right through to commercial supply.We manufacture a comprehensive range of tablets, capsules, and oral liquid products, supported by integrated packaging, labelling, QP release, storage and global distribution to both EU and UK markets.Our Non-Sterile Manufacturing CapabilitiesTablets (Active & Placebo)Throughput capacity of 40,000 tablets per hourTablet sizes 5 mm–25 mmFull GMP control of weight, hardness, friability, dissolution and uniformityCoated & uncoated tablet manufacturingProduction for Phase I, II, III and commercial supplyPlacebo tablets engineered to match active products in appearance, texture, taste, smell and disintegration, ensuring robust blinding for IMP trialsAnnex 13–aligned manufacturing and documentationCapsules (Active, Placebo & Over-Encapsulated)GMP capsule filling for early-phase through commercial supplyOver-encapsulation for comparator blindingFull shell, colour and size matchingWeight balancing and rattle preventionSuitable for complex blinding and randomised study designsSupports IMPs, comparators & NIMPsOral LiquidsGMP manufacturing of solutions and suspensionsTaste-masking for improved patient acceptabilitySuitable for Phase I–III and commercial supplyFull QC release testing and stability programme supportPlacebo Manufacturing & Blinding SolutionsEramol provides specialised placebo development and blinding services, including:Matched placebos (visual, sensory & functional attributes)Liquid placebo formulation & sensory matchingOver-encapsulation of tablets/capsulesPackaging and labelling blinding strategiesControlled processes to protect blinding integrity throughout the supply chainOur expertise ensures robust data integrity and regulatory compliance across Phase I–III studies.Integrated Packaging & Labelling ServicesEramol delivers full primary and secondary packaging services for non-sterile products:Primary PackagingBlisteringBottlingLiquid bottle filling (with tamper-evident seals)Single-dose& multi-dose formatsSecondary PackagingCartons, kits, and clinical study packsAncillary managementFull reconciliation and batch documentationGMP Labelling ServicesSingle-panel labelsBooklet labelsJust-In-Time (JIT) clinical labellingRegulatory and multilingual label controlVerification systems supporting Annex 13 and commercial requirementsThese services integrate seamlessly with QP release and global distribution.QP Release, Regulatory Support & ComplianceFounded by two Qualified Persons, Eramol operates with quality at its core.We provide:UK & EU QP certificationIMP & commercial batch releaseAnnex 13 and EU GMP guidance throughout developmentInspection-ready documentationEarly regulatory input to reduce risk and shorten timelinesOur internal QPs ensure full compliance for both clinical and commercial non-sterile manufacture.GMP Storage & Global DistributionEramol offers controlled storage environments across:Ambient2–8°C-20°C-80°CGlobal distribution services include:GDP-certified courier networkValidated shipping systemsTemperature monitoring & chain-of-custodyGlobal clinical site fulfillmentThis ensures safe, compliant delivery from manufacturing to trial or commercial destinations.Why Choose Eramol for Non-Sterile Manufacturing?End-to-end service from formulation → manufacture → packaging → labelling → QP release → storage → global distributionSupports Phase I, II, III, and commercial supplySevenoaks GMP facility operational since 2022Quality-first culture led by QP foundersExcellence in placebo matching, over-encapsulation and blindingHigh-throughput capability (40,000 tablets/hour)Flexible batch sizes ideal for clinical and niche commercial supplyStrong regulatory, QP and GMP complianceSingle-provider efficiency and reduced supply chain risk