We provide services including research project initiation, R&D strategy guidance, regulatory registration consultation, technical consulting, review of application documents, and mock inspections. To date, we have successfully completed dozens of technical service projects and guided multiple oral solid dosage forms through generic drug consistency evaluation studies.
With our professional registration team and expert advisors, coupled with an in-depth understanding of domestic and international registration regulations and pharmaceutical production laws, we ensure that projects meet domestic registration requirements and obtain approval smoothly.
To date, we have provided over 100 formulation registration, API registration, generic drug consistency evaluation, and pharmaceutical registration consultation services to domestic and international clients. Our experience includes multiple on-site inspections for research and production license approvals conducted by national and provincial regulatory authorities.