Services

Import & Product Release

Farmalyse is accredited(shortly) with a Manufacturing and Import License for Imports and final Product Release. These services are especially tuned for imported formulations and raw materials from production sites established outside of the European Union – namely India, China, Latin-America.

With the availability of 3 Qualified Persons and senior Quality Assurance personnel round-the-clock, you can rest assured we have the resources and expertise to manage big volumes of projects and release products in compliance with EU regulations, within a limited execution time. Our experience coupled with that of our professionals helps in providing you with the most efficient, flexible and reliable Import & Product Release services.

Services in a nutshell include a comprehensive package of

  • Qualified Person Release
  • Import & Sampling
  • Customs Clearance & Fiscal representation
  • Contact with NCTS
  • Bonded warehousing
  • Management T1-documents
  • Import/export certificates
  • Fiscal representation

Batch Release Services are offered on a routine basis for Pharmaceuticals manufactured inside and outside of the EU. The EHS works with 3 Qualified persons to ensure the release process is efficient and reliable while being tailored to the specific needs of our clients

Services offered in this spectrum are:

  • Pharmaceutical Import for outside of the EU (Import Site)
  • Audits, QP Declarations, Qualified Person Release
  • Auditing and Monitoring services.
  • Implementation services (GMP).
  • GMP Audits API suppliers and CMO’s
  • Pharmacovigilance, PIL Readability testing



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