EXPERTISE

Having worked with leading biotech and pharma companies from all across the globe, SHL understands that stringent quality control, streamlined communication, and speed-to-market are crucial for the success of drug-device development. For this reason, we continue to invest in the improvement of our internal expertise, offering a comprehensive range of services to meet our customers’ project requirements.

Our international team of dedicated professionals work around the clock to ensure that customer expectations are met and final products are delivered at optimal quality and speed.

EXPERTISE

Having worked with leading biotech and pharma companies from all across the globe, SHL understands that stringent quality control, streamlined communication, and speed-to-market are crucial for the success of drug-device development.

For this reason, we continue to invest in the improvement of our internal expertise, offering a comprehensive range of services to meet our customers’ project requirements.

Our international team of dedicated professionals work around the clock to ensure that customer expectations are met and final products are delivered at optimal quality and speed.

  • RESEARCH & INNOVATION

    • Extensive understanding of industry trends
    • Developing technologies for real user needs
    • Innovations beyond injection devices
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    The patient is at the center of everything we do. That is why we pay close attention to understanding real user needs. Through multilateral approaches of research and analysis, we build data-driven solutions that bring value to all stakeholders. Our engineers team up with software/hardware specialists to bring to life the technologies of the future.

  • DESIGN & ENGINEERING

    • Strong relationships with clients
    • In-house industrial design team and usability experts
    • Innovative award-winning designs
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    Key to SHL’s success is the way we listen to our clients. SHL has a strong in-house team of industrial designers and engineers who work closely with customers to ensure that their needs are elegantly translated into the design of the device. Our success is reflected in our growing number of launched products and broad pipeline of breakthrough injection devices that continue to reshape the industry.

  • PROJECT MANAGEMENT

    • Dedicated project managers
    • Stage Gate program management
    • Risk management
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    Each customer project is assigned a dedicated project manager, who leads a team to address the project’s engineering, clinical, regulatory, quality, and manufacturing tasks based on the “Stage Gate” process along with risk management plans. We apply a scientific approach when performing simultaneous engineering to achieve quicker response times, faster product development, and reduced waste.

  • FINAL ASSEMBLY, LABELING & PACKAGING

    • Faster time to market
    • Proven program management
    • Compliant with regulatory requirements for medical devices and pharmaceutical packaging and distribution
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    SHL offers final assembly, labeling, and packaging services for SHL-designed drug delivery devices. By offering a full turnkey solution from device development through to distribution, SHL is able to help clients decrease timelines to the clinic and/or commercialization for patients in need.

  • INTELLECTUAL PROPERTY

    • Large, strong IP portfolio
    • Commitment to protecting and defending SHL’s IP
    • In- and out-licensing opportunities
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    SHL has developed a comprehensive IP portfolio strategy that focuses on safeguarding and defending the IP of our products and offerings. To meet this goal, we have an in-house team of IP experts to support our own as well as our customers’ needs. Long-term strategies and investments have enabled us to provide our customers with thoroughly protected and bespoke solutions for their market needs.

  • REGULATORY AFFAIRS & COMPLIANCE

    • Compliance with medical device GMP
    • Regulatory lifecycle management
    • Support for global marketing regulatory accreditation
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    SHL has established regulatory services that can cover the entire regulatory lifecycle management of SHL products. Based on regulatory requirements and customer expectations, we offer a full range of regulatory support, including manufacturing registration, device filing, and post-market activities. We have successfully assisted our customers with obtaining regulatory approval in a number of countries around the world.

  • QUALITY SYSTEM

    • Company-wide quality program
    • ISO 13485 certification
    • FDA 21 CFR 820 compliant quality system
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    We build quality into every step of our development process, from planning to mass production. SHL has implemented a quality system that complies with FDA 21 CFR 820 and ISO 13485. This is regularly audited by customers and monitored by us through our internal audit procedures.

    We also stringently test all materials to comply with international safety requirements.

    SHL Medical ISO 13485 Certification

    The certificate is for use of SHL's authorized individuals, and/or companies. Any use of the certificates without SHL's prior written authorization is strictly prohibited.

  • GLOBAL SUPPLY CHAIN

    • Global logistics expertise
    • Global sourcing network
    • Sales and operations planning (S&OP)
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    SHL manages and supports a comprehensive supply chain for our customers from all over the world. This network consists of the most competent vendors that meet our high quality and operational standards. We follow strict quality control measures, which include auditing and fully certificating capable suppliers. Our focus on Supplier Excellence allows us to uncover and realize new synergies and decrease risk of failure.