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Formulation Guidelines


Quality is the cornerstone of everything we do. From initial product research through final product delivery — and beyond, thanks to our exceptional post-sale service and support — our business is built on offering customers an unmatched quality experience.


In practice, quality means adhering to the highest industry standards every step of the way. NuSil is ISO 9001 certified, and we use ISO standards throughout our worldwide operations. In addition, our proprietary quality system, NQS™, is certified and compliant with the following standards:

  • AS9100 – Quality Management Systems (QMS) Requirements
  • 21 CFR Part 210 & 211 cGMP for Finished Pharmaceuticals
  • ICH Q7 GMP Guidance for Active Pharmaceutical Ingredients
  • IPEC Americas GMP for Pharmaceutical Excipient

Relevant application of the following industry standards is addressed as part of NQS:

  • 21 CFR Part 820 QSR for Medical Device
  • ISO13485 QMS for Medical Device
  • EFFI GMP for Cosmetic Ingredients

To download relevant ISO certificates and other relevant supply chain documents, click below:


Testing is performed on instruments that have been calibrated in conformance with ANSI Z540-1 and ISO 17025, and traceable to National Institute of Standards and Testing (NIST). Product quality is assured by NQS, which begins with an effective design protocol and continues up the supply chain, from vendor qualification through product distribution.

Scheduled reviews of internal audit reports, product performance metrics and customer feedback provide strategic insight into the ongoing effectiveness of NuSil's quality policy and commitment to customer and corporate satisfaction.