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, 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. 

• ISO 13485

• IMC-GMP