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SFL Regulatory Affairs & Scientific Communication Ltd.
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Quality Assurance & GxP Compliance

Ensure quality compliance from quality management systems (QMS) establishment to quality oversight of marketed products.

Based on in-depth and long-term experience, we provide strategic and hands-on operational QA support to pharmaceutical and biotech companies marketing and developing drugs, biologics and gene therapy products.

The SFL Quality team establishes QMSs for both headquarters and affiliates. We prepare establishment license applications and provide full inspection readiness services. We also support QMS maintenance by auditing client and contractor facilities (including CMOs) for qualification and re-qualification purposes. Furthermore, SFL team members ensure quality oversight of marketed products by acting as EU qualified person (QP), local Swiss responsible person (RP) and/or deputies on a mandate basis.

  • Services

  • Regulatory Affairs
  • Quality Assurance & GxP Compliance
  • Medical Affairs & Communication
  • Market Access & Reimbursement
  • Public Affairs & Regulatory Intelligence
  • Medical Devices, Combination Products and IVDs
  • Pharmacovigilance & Clinical Safety
  • Supply Chains of Medicines and Devices
  • Legal & Healthcare Compliance
  • Swiss Support
  • UK Support
  • Clinical Trials support

Switzerland – Main Office

SFL Regulatory Affairs & Scientific Communication GmbH
Aeschenvorstadt 52 | CH-4051 Basel
Email: office@sfl-services.com
Phone: +41 61 361 9443

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