Batch Testing & Batch Release

btbr.jpegBoth laboratories, KYMOS and PHARMAPROGRESS are GMP certified and we have a partial manufacturer authorization for Quality Control purposes. We offer the following services:

  • APIs Certificate of Analysis according to the relevant Pharmacopoeias
  • Individual parameter determination to be included in your Certificate of Analysis
  • Full analysis of all parameters to issue a stand alone Certificate of Analysis
  • Batch Testing and Batch Release of clinical batches
  • Batch Testing and Batch Release of marketing batches
  • Importation into the EU of medicinal drug products (human, veterinary or investigational)

 

Batch Release Services

According to EU regulations, medicinal products imported into the European Economic Area (EEA) from third countries have to be certified by a Qualified Person (QP) to be released into the market. Companies based in countries with Mutual Recognition Agreements have no obligation to retest the batches, although batch certification is always required. KYMOS offers:

  • Manufacturing plant certification for EU-GMP compliance
  • QP declaration for regulatory purposes
  • Import of batches
  • Batch Testing and Certificate of Analysis
  • Documentary review
  • Batch Certificate for release

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