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Quality Control
Our state-of-the-art microbiology, biochemistry and analytical chemistry labs at all sites offer certified analytical methods for biologics characterization. We follow GMP guidelines and meet the regulatory authorities’ requirements for the analytical determination of your product’s general characteristics, molecular structure determination, identity, activity, purity and safety, as well as the stability of the produced therapeutic proteins, vaccines, live microbial products, plasmid DNA, mRNA and LNPs.
Our services include:
- Quality system inspected by FDA, EMA, ANVISA (Brazil), MFDS (Korea), PMDA (Japan) and others
- GMP and manufacturing licenses according to applicable local law
- Release of batches by Qualified Person (QP)
- 30+ years of commercial bioproduction without critical or major findings by authorities
- Quality support through the whole lifecycle of your product
- Review and support of writing of the CMC-related sections of your dossier or application