Eramol | Non Sterile Clinical Facility

https://eramol.com/clinical-services-category/non-sterile-manufacturing/ Eramol Non-Sterile Manufacturing GMP Production of Tablets, Capsules & Oral Liquids for Phase I–III and Commercial Supply Eramol 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 Capabilities Tablets (Active & Placebo) Throughput capacity of 40,000 tablets per hour Tablet sizes 5 mm–25 mm Full GMP control of weight, hardness, friability, dissolution and uniformity Coated & uncoated tablet manufacturing Production for Phase I, II, III and commercial supply Placebo tablets engineered to match active products in appearance, texture, taste, smell and disintegration, ensuring robust blinding for IMP trials Annex 13–aligned manufacturing and documentation Capsules (Active, Placebo & Over-Encapsulated) GMP capsule filling for early-phase through commercial supply Over-encapsulation for comparator blinding Full shell, colour and size matching Weight balancing and rattle prevention Suitable for complex blinding and randomised study designs Supports IMPs, comparators & NIMPs Oral Liquids GMP manufacturing of solutions and suspensions Taste-masking for improved patient acceptability Suitable for Phase I–III and commercial supply Full QC release testing and stability programme support Placebo Manufacturing & Blinding Solutions Eramol provides specialised placebo development and blinding services, including: Matched placebos (visual, sensory & functional attributes) Liquid placebo formulation & sensory matching Over-encapsulation of tablets/capsules Packaging and labelling blinding strategies Controlled processes to protect blinding integrity throughout the supply chain Our expertise ensures robust data integrity and regulatory compliance across Phase I–III studies. Integrated Packaging & Labelling Services Eramol delivers full primary and secondary packaging services for non-sterile products: Primary Packaging Blistering Bottling Liquid bottle filling (with tamper-evident seals) Single-dose& multi-dose formats Secondary Packaging Cartons, kits, and clinical study packs Ancillary management Full reconciliation and batch documentation GMP Labelling Services Single-panel labels Booklet labels Just-In-Time (JIT) clinical labelling Regulatory and multilingual label control Verification systems supporting Annex 13 and commercial requirements These services integrate seamlessly with QP release and global distribution. QP Release, Regulatory Support & Compliance Founded by two Qualified Persons, Eramol operates with quality at its core. We provide: UK & EU QP certification IMP & commercial batch release Annex 13 and EU GMP guidance throughout development Inspection-ready documentation Early regulatory input to reduce risk and shorten timelines Our internal QPs ensure full compliance for both clinical and commercial non-sterile manufacture. GMP Storage & Global Distribution Eramol offers controlled storage environments across: Ambient 2–8°C -20°C -80°C Global distribution services include: GDP-certified courier network Validated shipping systems Temperature monitoring & chain-of-custody Global clinical site fulfillment This 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 distribution Supports Phase I, II, III, and commercial supply Sevenoaks GMP facility operational since 2022 Quality-first culture led by QP founders Excellence in placebo matching, over-encapsulation and blinding High-throughput capability (40,000 tablets/hour) Flexible batch sizes ideal for clinical and niche commercial supply Strong regulatory, QP and GMP compliance Single-provider efficiency and reduced supply chain risk