REGULATORY AFFAIRS & COMPLIANCE

Compliance with Medical Device cGMP Project development regulatory compliance
Regulatory life-cycle management Global premarket regulatory applications
Support for global marketing regulatory accreditation Product post-approval regulatory support

COMPLIANCE

SHL has established regulatory services that can cover the entire regulatory life-cycle management of SHL products. Based on regulatory requirements and our customer's expectations, we offer a full range of regulatory support, including manufacturing registration, device filing and post-market activities.

SHL is subject to global and local government regulations, most notably the requirements of US Food and Drug Administration (FDA), the European Union and other major markets worldwide. While it is typically our pharmaceutical partners who undertake the application of regulatory approval for their finished injection devices, we understand that this process is lengthy, expensive, and often subject to unanticipated governmental requirements. Therefore, we share our knowledge learned from past experiences corresponding with relevant authorities, and offer our customers full support during the application process via a team of experienced regulatory experts who are familiar with the stringent "review to approval" processes in various countries.

REGULATORY APPROVAL

Complying with extensive regulations regarding the safety, efficacy and overall quality of all our products, we have successfully assisted our customers with obtaining regulatory approval in North America, Europe, Asia and beyond. We also support our customer's clinical trial applications, New Drug Applications (NDA) or Biologic License Applications (BLA).