Ensera is a global partner for pharmaceutical and drug delivery companies, specializing in the design, development and manufacturing of complex combination and parenteral products.

We combine device expertise with GMP-compliant manufacturing to support programs from development through to final assembled and packaged product.

Working across the post-fill value chain, Ensera helps pharma companies bring injectable therapies to market with greater speed, flexibility and control.

Core pharma services

• Final assembly, kitting and secondary packaging of parenteral products
• Labeling, serialization and aggregation for global markets
• Support for vials, pre-filled syringes, autoinjectors and pen systems
• Flexible manufacturing from clinical supply to low–medium volume commercial launches
• Management of complex, multi-component products and multi-SKU packaging
• Sterilization management, validation and supply chain coordination

Locations and infrastructure

• GMP-certified facilities in Europe, North America and Southeast Asia
• Cleanroom manufacturing environments (ISO 7 / ISO 8)
• Cold chain storage with monitored temperature control
• Integrated digital systems supporting traceability and manufacturing control

Regulatory support

• ISO 13485-certified quality management systems
• Registration with major global regulatory authorities including FDA and EMA
• In-house validation, testing and regulatory support services
• Serialization and traceability to meet global compliance requirements

Design & Product Development

• End-to-end design and engineering for drug delivery and combination products
• Human factors, prototyping and testing capabilities
• Integrated design-to-manufacturing to reduce handoffs and risk
• Experience across autoinjectors, inhalers, pre-filled syringes and other devices

Ensera is built for programs where complexity, speed and flexibility matter most. Unlike traditional high-volume CDMOs, it is designed to support lower-volume, high-value products and variable demand.

By combining device design, assembly and packaging within a single partner, Ensera reduces operational complexity and helps pharma teams bring products to market with greater confidence.

Get in touch here to tell us about your project.

Case studies

Supporting ultra‑low‑volume orphan drug launches with complex secondary packaging

Enabling smooth, dual-market delivery of a kitted PFS biosimilar requiring terminal sterilization

Accelerating European market entry for Asia-manufactured biosimilars

Custom washing and packing of ready-to-use (RTU) Annex 1 compliant components

News and blogs

Designing resilience into global drug launches

Navigating MDR Article 117 amid rising demand for autoinjectors and prefilled syringes

The impact of GLP-1 demand on the autoinjector supply chain

Why low volume pharma projects struggle to find the right assembly & packing partner – and how  Ensera fills the gap