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Consultation Services

Chemistry, Manufacturing and Control (CMC) Consultation services


Nextar provides quality Chemistry, Manufacturing, and Controls (CMC) consulting services. Our experts see themselves as an integral part of your  team from the inception of your project. The CMC team provides essential guidance, based on thorough knowledge of the EU and US Regulatory Guidelines  and can serve your needs to  receive  independent Regulatory Affairs (RA) and Quality Assurance (QA) support, complementary to your team, for your programs.


Our CMC consulting services include identification of information required for regulatory submission, including :

  • Strategic CMC regulatory advice, planning, and Gantt charts including gap analysis
  • Analytical specifications, method validation and minimum stability data requirements
  • Provision of suitable plans of development
  • Formulation development, analytical, stability and production data
  • Preparation of test articles for toxicology, and clinical studies
  • Bio-analytical services for preclinical and clinical studies

 

Quality consulting services:  

Quality Assurance experts in Nextar are experienced in implementation of quality assurance  systems  of the following set of rules:

  • Design and planning of a quality system (whether according to a single or multiple set of requirements)
  • Training and instructions
  • Assessment of the level of implementation of requirements
  • Good Manufacturing Practices (GMP) including according to ISO 13485
  • Good  Laboratory Practices (GLP)
  • Requirements for the laboratories’ competence according to ISO/IEC 17025
  • ISO /IEC 9001