Injection systems
Prefilled syringes, autoinjectors, cartridge systems, multi-use pens, needles, and needle-safety devices.
Combinate BioWorks
Combination product design controls.
Align design controls, risk management, control plans, verification and validation, design transfer, release testing, and lifecycle change across drug and device teams.
Product applications
Delivery systems, platforms, and therapies.
Design-control and lifecycle experience across integrated drug-delivery systems from development and transfer through launch and commercial scale.
Infusion and renal systems
IV bags, infusion devices, peritoneal dialysis bag systems, cyclers, and disposable sets.
Vial-based and kitted systems
Vials, transfer and spike adapters, combination product kits, and administration components.
Respiratory and implanted systems
Nasal and inhalation systems, associated delivery components, and implanted combination products.
Design and lifecycle scope Requirements, design controls, risk management, verification and validation, control plans, sampling strategies, design transfer, launch, and lifecycle change.
Therapeutic contexts Vaccines, biologics, small molecules, antibiotics, generics, and diluents.
Design controls support for development, transfer, and change.
Support can focus on a new combination product program, an established platform, or a defined design-quality gap.
Design controls assessment
Assess plans, procedures, design and development documentation, traceability, and evidence against the applicable framework.
Design quality planning
Define the quality plan, stage expectations, responsibilities, review points, and documentation strategy for the program.
Risk and traceability integration
Connect user needs, design inputs, risks, controls, verification, validation, and production controls.
Verification, validation, and sampling strategy
Define evidence expectations, acceptance criteria, quality review points, and risk-based sampling approaches.
Design transfer readiness
Assess documentation, process, supplier, site, and acceptance-readiness before transfer or commercial scale-up.
Lifecycle change assessment
Evaluate product, process, supplier, manufacturing, risk, testing, and validation impacts for commercial changes.
Services include assessment, quality strategy, framework and procedure development, and technical review. Engineering design, execution of verification or validation testing, and submission authorship remain outside the service unless separately scoped.