We understand the needs of our customers, combine the domestic and international research situation, the status quo of cutting-edge technology and the current development trend, and customize a unique and scientific clinical research plan according to the characteristics of the product itself.

All team members have many years of professional medical writing experience, with doctoral or master's degree in clinical medicine/pharmacy, to ensure the quality of research documents, endocrine, infection, oncology, cardiovascular and other fields are involved. Rigorous and perfect SOP, personalized and customized quotation system can provide you with the design and writing of all kinds of medical research documents according to the demand.

• Clinical trial protocols (including phase I-IV, BE trials, real-world studies, exploratory studies for new indications, initial protection of TCM and renewal of TCM, etc. for TCM, chemotherapeutic drugs and biologics)

• Literature search and review related to clinical studies

• Ethical information (CRF, ICF, SD, etc.)

• Investigator's manual

• Writing of medical papers, research reports, etc.

• Clinical research summary report

The team is experienced in registration and familiar with the relevant regulations of ICH and Chinese regulatory authorities, and accurately grasps the pulse of the industry. We have established long-term and effective communication with industry experts and regulatory bodies, and can provide services such as regulatory affairs and product registration. Our registration team is well versed in the review and approval process of various types of products, including chemical drugs, biological products, traditional Chinese medicines, medical devices and so on.

Services include:

• Regulatory Consultation: Feasibility study for the registration of traditional Chinese medicine, chemical medicine, biological product, medical device, development of registration strategy, regulatory consultation for clinical research program, etc.

• Pre-filing communication and meetings with regulatory authorities

• Clinical trial approval application

• Genetic office approval application

• Clinical trial filing

• Assist in communicating with CDE for review

• Guide clinical trial site verification

• Assist in medical device registration inspection

• Assist in the registration filing of various types of drugs

PV's business team members all graduated from pharmaceutical-related majors, with an average of more than 4 years of work experience, rich industry experience and superb business proficiency can be a high standard, high demand for data processing and project execution, to bring reliable and safe management services to customers.

Services include:

• Assist in literature search and translation of product safety information.

• Reviewing case safety reports including medical coding, causality, anticipation and severity assessments, and medical challenge presentations

• Provide support for drug safety efforts

• Assist in the preparation of safety related documents such as risk management plans, pharmacovigilance plans, etc.