Quality and Compliance

When going on a clinical trial, your product needs to meet the regulatory requirements. Here at Nextar, we provide you with a full range of services in compliance with GMP, ISO13485, GLP, and IMC-GMP.

 

Our quality team can help you design and plan your activities according to the quality requirements for each developmental stage and in agreement with International requirements. The team includes a pharmacist in charge and a Qualified Person (QP), to support the release of your product for clinical trials.

We were successfully audited by the FDA and our site is subjected to frequent reviews of regulators as well as customers; hence remains in compliance with the highest standards of:

  • cGMP according to required regulations such as U.S FDA, ICH, EMEA. British MHRA Etc. 

  • GLP according to  OECD, European and US regulations 

  • ISO 13485

  • ISO 9001

  • IMC-GMP

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