Registration consultation services

Services Categories

Regulatory reference/Validation strategy

Simulated audit

Countries/Agencies GMP and   Appendix (clinical medication), Guideline

Audit readiness review

Countries/Agencies GMP and   Appendix (clinical medication), Guideline

Gap analysis report

Countries/Agencies GMP and   Appendix (clinical medication), Guideline

On-site inspection   assistance

Countries/Agencies GMP and   Appendix (clinical medication), Guideline

Registration materials compilation

Countries/Agencies GMP and   Appendix (clinical medication), Guideline

Registration process service

Countries/Agencies GMP and   Appendix (clinical medication), Guideline

IND   application materials compilation

Countries/Agencies GMP and   Appendix (clinical medication), Guideline

IND application process service

Countries/Agencies GMP and   Appendix (clinical medication), Guideline

Preclinical and clinical development   planning

Countries/Agencies GMP and   Appendix (clinical medication), Guideline