Broad regulatory expertise – globally recognized
Woodstock Sterile Solutions is approved to ship finished products to multiple countries on five continents. 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.
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
Article: Mitigating Risks Associated with Aseptic Parenteral Filling
Article: Blow-fill-seal Technology Advances in Aseptic Filling Applications
E-Book: Extractables & Leachables: Understanding Container & Device Interactions
E-Book: BFS Solutions for Inhaled and Biologic Therapies
Infographic: A Primer on Blow-Fill-Seal (BFS)