Regulatory services are the activities that ensure the compliance of clinical trials with the applicable laws, regulations, and guidelines of the relevant authorities and agencies. Regulatory services are essential for obtaining and maintaining the approval and authorization of clinical trials, as well as ensuring the safety and quality of the products and processes involved. Landmark CRO offers the following regulatory services:
Regulatory Strategy And Consultation
Regulatory Document Preparation And Submission
Regulatory liaison And Communication
Regulatory Strategy And Consultation
Landmark CRO helps develop and implement the optimal regulatory strategy for each clinical trial, based on the product type, indication, target market, and regulatory environment. Landmark CRO also provides consultation and advice on the regulatory requirements, standards, and best practices for the design, conduct, and reporting of clinical trials, as well as the preparation and submission of regulatory documents.
Regulatory Document Preparation And Submission
Landmark CRO prepares and submits the required regulatory documents for each clinical trial, such as the investigational new drug (IND) application, the clinical trial application (CTA), the ethics committee (EC) or institutional review board (IRB) application, the informed consent form (ICF), the clinical trial protocol, the clinical trial notification (CTN), and the clinical trial registration (CTR). Landmark CRO also ensures the accuracy, completeness, and consistency of the regulatory documents, as well as compliance with the format and content specifications of the relevant authorities and agencies.
Regulatory liaison And Communication
Landmark CRO acts as the liaison and communication channel between the sponsor, the investigator, and the regulatory authorities and agencies, such as the Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Central Drugs Standard Control Organization (CDSCO), and the National Medical Products Administration (NMPA). Landmark CRO facilitates and coordinates the regulatory interactions, such as the pre-IND meeting, the scientific advice meeting, the pre-submission meeting, and the post-approval meeting. Landmark CRO also handles and responds to the regulatory queries, comments, and feedback, as well as the regulatory amendments, variations, and notifications.
