As part of GCP ClinPlus's more than 20 years of professional clinical CRO, our registration department focuses on providing full process registration services for new drugs, particularly in the field of cell and gene therapy (CGT).

Service Content

Full process registration support

Provide the writing, technical analysis, and registration management of all General Technical Documents (CTD) related to pharmacy, non clinical, and clinical stages

Registration Strategy Consulting

Based on a deep understanding of the CGT field, we provide targeted registration strategy consulting and policy interpretation to help clients develop efficient registration plans

Regulatory Trends and Scientific and Technological Grasping

Keeping up with regulatory trends and the development of science and technology, providing customers with the latest professional opinions and suggestions, helping them strive for policy dividends and seize market opportunities

Comprehensive regulatory communication

Maintain close contact with regulatory agencies, provide comprehensive regulatory communication services, and ensure the smooth progress of the registration process

Medical Device Registration Services

Provide registration services for medical devices, especially consultation and declaration services for drug device combination and joint device registration

Service Features

TEAM

The team members include members of the Device Evaluation Professional Committee, CDE data statistics experts, as well as clinical and pharmaceutical experts. Their professional background and rich experience give us a unique advantage in the field of registration affairs

Success Cases

With over 20 years of experience, we have successfully assisted in the approval of the first domestic stem cell new drug, demonstrating our outstanding capabilities in the field of registration affairs

Efficient process

The registration process is efficient and targeted, providing customers with fast and effective registration services

Good communication network

Established a good communication network with CDE reviewers, researchers from the China Inspection Institute, and the verification center to ensure a smooth registration process

Comprehensive consulting services

Provide comprehensive registration related consulting services, covering pharmaceutical, non clinical, and clinical stages, to ensure that clients' registration applications comply with the latest regulatory requirements

Through professional registration services, GCP ClinPlus is committed to helping clients stand out in the fiercely competitive market and successfully achieve their goals of launching new drugs and medical devices. Looking forward to working together with you to promote the progress and development of medical technology.