Clinical Supplies & Commercial Manufacturing Support
Drug development often gets stuck at the point of clinical and commercial manufacture. A limited number of sterile filling suppliers, varying levels of technical maturity among Contract Manufacturing Organizations (CMOs), difficulties in filling high-viscosity products, and a lack of scalable manufacturing platforms can impact timelines, increase the cost of goods, and jeopardize regulatory approval. Complex dosage forms, such as ophthalmics, injectables, semisolids, transdermals, and drug–device combination products, require CMOs with specialized infrastructure, high-containment systems, and demonstrated experience in global regulatory filings. Choosing the wrong business partner can restart packaging, cause supply interruptions, and lead to a poor long-term commercial deal.
Healios mitigates these risks through comprehensive technical consulting and CMO identification services for clinical trial supplies and commercial manufacturing. We connect sponsors with CMOs that deliver reliability, scalability, and long-term compliance through our extensive process-engineering expertise, QbD-driven manufacturability assessments, and global regulatory intelligence. Our network of more than 50 vetted CMOs across the USA, India, Europe, the UK, Canada, Japan, South Korea, Taiwan, China, and APAC covers all dosage forms supported by Healios. These dosage forms include topicals, transdermals, ophthalmics, otics, injectables (SVP/LVP), nasal sprays, implants, inserts, and oral liquids.
Healios identifies Advanced CMO capabilities.
- We offer flexible batch sizes starting from grams to tons.
- Methods for advanced processing such as hot-melt extrusion, cryogenic milling, and others.
- Fill-finish for ophthalmic gels, long-acting injectables, emulsions, suspensions, semisolids, high-viscosity complexes.
- Creating advanced drug and device combination products: integrated development, device design, prototyping, tooling, assembly, fill–finish, and performance qualification.
- Sterilization, which is aseptic and terminal (mostly steam, EtO, gamma, e-beam)
- Production of products that are hormonal, cytotoxic, potent, and controlled substances.
- We offer complete packaging and serialization for a range of options, including BFS Vials, PFS Cartridges, and more!
International logistics, cold-chain management, and clinical supply distribution compliant with GDP.
Healios works with CMOs audited by the US FDA, EMA, MHRA, Health Canada, and PMDA, and is known for strict compliance with global GMP standards. The facilities use strong quality systems, validated equipment trains, strong documentation controls, and proven inspection histories. They have highly experienced technical and QA teams that deliver consistent supply reliability, reproducible batch performance, and regulatory-ready documentation, including master batch records, technology-transfer packages, and CMC modules, enabling an efficient path into global markets.
As part of a long-term growth strategy, Healios is developing an ophthalmic BFS platform and a sterile injectable LVP facility in New Jersey, enhancing its development-to-commercial readiness capabilities.
