SHL (Scandinavian Health Ltd.) is the world's largest privately-owned designer, developer and supplier of advanced drug delivery devices.
Auto Injectors and Pen Injectors
SHL manufactures an extensive range of auto injectors and pen injectors that re-define the self-injection process by making them simple, safe and reliable. Their auto injectors are designed to make administrating drugs easier and more consistent than manual injections, improving patient compliance and ensuring successful therapy delivery. More recently developed auto injectors include features such as:
- Enhanced safety
- Intuitive use and ergonomic design
- Reduced number of components
- Two-step or three-step operation
- Compact design
- Inter-lock systems with sequential control and non-sequential control
- Ability to accommodate range of viscosities
Design Expertise for Drug Delivery DevicesAuto Injectors and Pen Injectors
SHL's concept development and innovative design takes place at their design centers in Sweden and the US, where experienced engineers develop product enhancements and breakthrough drug delivery solutions.
Significant investment in R&D over the past ten years has enhanced their broad pipeline of 'next generation' drug delivery devices. These include a range of disposable and reusable auto injectors and/or pen injectors with fixed or variable dosing, enhanced precision and the ability to accommodate high viscosities.
Developing these drug delivery devices in-house allows SHL to customise existing devices in their pipeline or develop completely new devices based on the unique customer requirements.
Regulatory Knowledge and Experience for Auto Injectors and Pen Injectors
SHL complies with extensive regulations regarding safety, efficacy and overall quality of their products, which have 510(k) clearance according to the Federal Food, Drug and Cosmetic Act.
SHL is also subject to government regulations, most notably from the Food and Drug Administration (FDA) in the United States.
Typically, it is their pharmaceutical partners who undertake the application of regulatory approval for their finished injection devices, however, SHL understand that this process is lengthy, expensive, and subject to unanticipated delays. Therefore, the leaders in Aunto and Pen Injector manufacturing offer customers full support during the application process via a team of regulatory experts who are familiar with the stringent accreditation processes in various countries.
SHL have successfully assisted customers in obtaining regulatory approval in North America, Europe and Asia. For their US customers, they will support New Drug Applications (NDA) or Biologic License Applications (BLA) with the FDA as their established 510(k) clearance will help ease this process. SHL is also recognised by the Japanese Minister of Health, Labor, and Welfare (MHLW)as an Accredited Foreign Manufacturer (AFM) and their manufacturing facilities comply with Ministerial Ordinance No. 169.
Beyond market clearance, SHL complies with all applicable general controls. This includes establishment registration, device listing, post-market surveillance, medical device reporting and compliance with the FDA's Quality System Regulations (21CFR 820).
In-house drug delivery device manufacturing capabilities
To maximize quality control during the manufacturing process of drug delivery devices such as auto injectors and pen injectors, SHL have invested heavily over the years in bringing vital capabilities in-house, ensuring every step can be monitored and needed adjustments made in a timely manner. Some capabilities include:
- Tooling: advanced in-house tooling centre for drug delivery devices
- Molding: extensive range of molding solutions
- Automation: design and build customized assembly and testing equipment
- Assembly: semi-automatic and fully-automatic assembly solutions
- Final Packaging and Assembly: Final assembly, labeling and packaging services for drug delivery devices
With such a range of capabilities available in-house, SHL helps address the time-to-market issue that customers often face and truly becomes a one-stop shop.
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