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Avecia’s Quality unit includes Quality Assurance, Regulatory Support, and our Validation department. Our two facilities are FDA registered, and produces API, adjuvants and intermediates that meet 21 CFR Part 210 and 211 as interpreted by ICH Q7 “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients” for CGMP production. We have the most extensive late phase portfolio of any oligonucleotide CMO, and our regulatory systems have been updated to reflect the needs of commercial products. At Avecia, we pride ourselves on having a superior quality program that benefits all of our customers, at all phases of development.

Quality Assurance and Regulatory

Avecia takes a proactive approach to regulatory excellence; we have had four successful FDA inspections at both facilities and undergo approximately 10-15 client audits per year. In addition, Avecia has been audited and approved by every top pharma company with an active, outsourced oligo program.

Our Quality Assurance team works with all Avecia departments to ensure compliance with:

Quality System Regulation and Current Good Manufacturing Practices (CGMP) as per the USFDA 21 Code of Federal Regulation (CFR) Parts 210 and 211

International Conference for Harmonization (ICH):

  • Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (API) Q7 Pharmaceutical Development Q8
  • Quality Risk Management Q9
  • Pharmaceutical Quality System Q10
We offer additional benefits to our customers, including the writing or review of Chemical, Manufacturing & Controls sections for INDs or NDAs and/or A1 sections for BLAs , as well as prepared templates for Quality Agreements. All customer projects are assigned an experienced Avecia Quality Assurance representative, to ensure that all appropriate regulatory and quality procedures and requirements are followed.
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