Regulatory Capability

Broad regulatory expertise – globally recognized

Woodstock Sterile Solutions is approved to ship finished products to more than 65 countries around the world. We maintain approvals from major regulatory agencies in pharmaceuticals, foods, supplements, and medical devices.

We are regularly audited by the FDA and international regulatory agencies and have achieved an excellent track record in these audits.

Woodstock Sterile Solutions produces sterile and non-sterile liquid drug products and combination devices regulated by the United States Food and Drug Administration (FDA) and parallel international agencies for distribution throughout the world. These products are made in compliance with Current Good Manufacturing Practice (cGMP) regulations under the jurisdiction of the FDA, the European Union, ANVISA, the International Council on Harmonization and other drug regulatory bodies as required.

US FDA
ANVISA
MHRA
European Medicines Agency
Health Canada

Broad Registration, Accreditations and Certifications

  • Registered for drug, combination device and food manufacturing with the U.S. Food and Drug Administration (FDA)
  • State license for wholesale drug and food manufacturing and distribution
  • cGMP Certifications through EU-competent authorities
  • Manufacturing accreditations for Japan
  • Potent material handling Safebridge 1-4
  • ISO 13485:2016 Certification
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