Regulatory Affairs
Navigating the complex regulatory landscape is crucial for the successful initiation and execution of clinical trials. Our team provides comprehensive support and expertise in regulatory compliance, ensuring adherence to local and international regulations throughout the trial lifecycle.
Equilab has proved that Material Transfer Agreement (MTA) is no longer a barrier in Indonesia’s clinical trials. We actively engage with Ministry of Health (MoH) to manage the negotiation, drafting, and execution of MTAs. Our Regulatory Affairs experts ensure compliance, protect intellectual property rights, and maintain confidentiality, facilitating the essential material exchange for your trial.
Material Transfer Agreement (MTA)
3.
Equilab can manage the import licenses necessary for the importation of investigational products and study-related materials into Indonesia. Our Regulatory Affairs team prepares the regulatory requirements, imports license applications, and liaises with relevant authorities to expedite the timely issuance of import permits. This ensures seamless supply chain management for your clinical trial.
Import License
2.
Equilab Regulatory Affairs experts facilitate the preparation, submission, and follow-up of Ethics Committee (EC) and Regulatory Authority (RA) dossiers, including those required by the Indonesian National Agency of Drug and Food Control (BPOM) or Ministry of Health (MoH). We collaborate closely with sponsors and investigators to compile complete and accurate submission packages, manage regulatory correspondence, and address queries or requests for amendments to secure timely approvals for trial initiation.