YOUR TIMELINE, OUR COMMITMENT
Regulatory Affairs
Import License
Management
Are you planning to use Investigational Pharmaceutical Products in Chile?
To ensure compliance with the country's regulations, it is essential to obtain an Import License from the Institute of Public Health of Chile (ISP).
This license authorizes the importation, distribution, and use of your products in Chile.
Regulatory Approvals
Our team is dedicated to facilitating the submission of the Clinical Study Protocol to Ethics Committees.
Through close collaboration with investigational sites, our goal is to secure all required ethical approvals promptly and efficiently.
Recognizing the critical significance of these approvals for the success of your study, we are committed to delivering the utmost support to ensure you reach your goals.
CTA Negotiations
Our team works diligently to assist the sponsor in obtaining the Clinical Trial Agreement (CTA) and approval for the Clinical Research Budget.
We engage with the research institution and principal investigator, ensuring that all negotiations are conducted with professionalism and efficiency.
You can trust in our commitment to delivering high-quality support to enhance the success of your clinical trial.
Legal Representation
Our legal representation services are tailored to support clients conducting clinical studies in Chile who lack local business representation.
We recognize the complexities of navigating Chile's Institute of Public Health (ISP) regulatory framework and protocols.
With our expertise, you can trust that your clinical study will adhere to ISP requirements and your interests will be diligently represented. Choose us for a seamless and stress-free process for your clinical study in Chile.
SAEs & AEs
It is of utmost importance to report any Serious Adverse Events and Safety Reports to the Institute of Public Health of Chile (ISP). Doing so will help ensure the safety and well-being of the public.
Let's work together to take proactive steps toward promoting healthier and safer clinical trials.
IP Warehouse Management
Our team oversees contracts with warehouses authorized by the Chilean regulatory authority (ISP) to guarantee compliant storage and handling of investigational products and clinical trial materials.
We handle all Comex activities required for a smooth import/export process.
Trust PRS to take care of all your warehousing and Comex needs.
