Nextar provides quality Chemistry, Manufacturing, and Controls (CMC) regulatory consulting services. Our regulatory and quality assurance experts are an integral part of the team from the inception of your project. They provide essential guidance, based on thorough knowledge of the EU and US Regulatory Guidances and can serve your needs to have independent Regulatory Affairs (RA) and Quality Assurance (QA) support for your programs.

*  Our CMC and RA consulting services include:

• Strategic CMC regulatory advice, planning, and Gantt charts.
• Development, preparation, and review of CMC documentation.
• Identification of CMC information appropriate for regulatory dossiers including determination of suitable.
• Analytical specifications, method validation and minimum stability data requirements.
• Define CMC requirements based on toxicology and clinical requirements.
• Provide development plans suitable for inclusion in investor meetings or proposals.
• Write development reports for inclusion in regulatory submissions.
• Draft, write, review and/or compile CMC sections of IND, NDA, CTA, ANDA, DMF, CTD and other regulatory applications.
• Prepare and/or review the following dossier sections.
• Quality Overall Summary, Drug Substance, Drug Product, Methods Validation, Validation of Sterilization Process.
• Write the P2 Pharmaceutical Development section of NDA applications.
• Vendor selection and qualification.
• QA/QC reviews and audits.

*  Quality consulting services: 

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

·         Good Manufacturing Practices

·         Good  Laboratory Practices

·         Requirements for the laboratories’ competence according to ISO/IEC 17025 as well as ISO /IEC 9001

Nextar experts consult their customers regarding the regulatory requirements relevant to the intended use of the products and analytical services Nextar provide them as well as on the implementation of the appropriate quality system in their own organization.

Among the services a customer may seek:

·         Gap analysis

·         Design and planning of a quality system (whether according to a single  or multiple set of requirements

·         Training and instructions

·         Revision of documents

·         Assessment of the level of implementation of requirements

*  GMP documentation management and electronic archiving