Quality Assurance & Regulatory

Quality Assurance

Avecia's OligoMedicines manufacturing facility is an Active Pharmaceuticals Ingredients (API) manufacturer meeting the International requirements addressed in Q7A (ICH GMP for APIs). The Milford facility is a FDA registered establishment with a FDA compliant profile.

We have undergone:

• three successful FDA inspections
• audited by c. twenty clients per annum
• audited and approved by six of the world's top ten pharmaceutical companies

At this facility, high quality, custom oligonucleotide APIs are manufactured to cGMP standards for utilization in pre-clinical and clinical trials, as well as launched products. Our Quality Systems assure that the quality of material being used is acceptable to Agency (FDA) regulations and patient safety. Our inspection record assures you, the customer, that the Quality Systems and Regulatory Compliance (Q7A and cGMPs) are being met at Avecia.

Regulatory

• maintenance of Regulatory Affairs Library
• DMF submission updates
• QA/QC review of customer prepared CMC sections
• customer interface via roundtable CMC review