Quality Assurance


Full complex support within CMC & Quality Assurance Compliance from QP services, EU Batch Release to complex certification of EUGMP by leading EU Authorities

At PharmAZet the enhancement and continuous improvement of Quality is the responsibility of every individual. As part of our intent focus of our customers' compliance needs, we conduct surveillance of new regulations, and monitor and implement new regulatory trends.

We acknowledge that it is essential to offer you full range of service within our own facility thus we have opened also our own Batch Release Site to provide you with access to ALL EU territory.

Our services include:

  • Gap analysis and remediation
  • Preparation of eCTD modules 2 and 3
  • DMF preparation
  • QP services
  • Import documentation and licensing
  • GLP/GMP audit
  • Pre-approval inspections – finished drug product or API
  • Batch release (EUBRS) and analytical testing for batches
  • Warehousing



The European chemical regulation REACH entered into force in June 2007. As a consequence, REACH companies using raw materials and other chemical substances, as part of preparations or articles need to take actions to secure their supply and use of these.

If you are a company manufacturing and importing substances into EU, you will have to register the substances at the chemical agency in Helsinki, Finland. We provide a very in-depth support in this area from:

  • REACH Consulting
  • REACH Registration
  • Late Pre-Registration
  • Registration (Joint, Inquiry, Lead, Intermediate)
  • REACH Analytical & Technical
  • CLP Regulation
  • Safety Data Sheet
  • Label
  • SVHC (Substance of Very High Concern)
  • Authorisation
  • Restriction
  • SIEF & Consortia Management

PharmAZet REACH advisory services are commercially and technically qualified to undertake any complex regulatory challenge, including:

  • Assessment of REACH on business (obligations, benefits of investment towards registration, market analysis)
  • Project Strategies (Identifying the most cost effective registration process and estimating time for project completion)
  • Examining and facilitating all other regulatory requirements.
  • Communication on hazards, usage of substances along the supply chain (manufacture, importer & downstream user)
  • Impact of regulation (methods of production, substance use as an intermediate, guidance on exemptions)

REACH will affect the chemical sector and beyond. If the necessary preparations have not been made, the implications on companies can be significant.




We are pleased to be able to offer a fully registered and certified EUBRS of Pharmazet Group to be able to deliver not only support during registration process with QP declaration but also actual product release based on sample testing to achieve maximal cost effectiveness for product market delivery within whole EU.

Our QPs are experienced, dynamic and committed professionals, used to solve challenges but always ready to deliver solution to fit your commercial plans.

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