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KLCRO is facilitating sponsors for conduction of clinical trials by acting a bridge between Health Ministry of Pakistan and sponsors (Pharmaceuticals, Alternative Medicines, Biotechnology Products and Medical Devices). The Drug Regulatory Authority of Pakistan (DRAP) regulates the conduct of clinical trials of therapeutic goods in Pakistan under the Bio-Study Rules 2017.
KLCRO provides regulatory services to the applicants in making new applications for clinical trials on therapeutic goods, or any subsequent submissions and regulatory requirements to be fulfilled. It also provides an outline on the procedure for submission, review, evaluation and proceeding for approval of applications for the conduct of clinical trials. We have expertise in:
The medical device industry is highly complex and demands a team of experts and specialists who have the knowledge and experience to navigate the regulatory landscape. At KLCRO, we understand the importance of strategic and clinical trial support for new diagnostic devices and indications. That’s why our medical device team offers a range of services including simple normal and healthy sample collection. Through this registration process, safe and dependable medical equipment that support the provision of high-quality healthcare services throughout Pakistan are made available to patients and healthcare practitioners.
In-depth documentation outlining the device’s specs, intended usage, manufacturing procedures, and clinical proof proving its safety and efficacy must be submitted to DRAP by manufacturers wishing to market medical devices in Pakistan. These submissions are assessed by DRAP to see if the device satisfies the prerequisites and standards for registration.
Rest easy knowing that our medical device staff are experts in managing studies across all therapeutic areas and phases including first in man, feasibility, pilot, pivotal, and late-stage registries. With their vast experience, they are more than capable of supporting your pre-market, post-approval, and post-market study endeavors throughout the device life cycle, regardless of the size and complexity of the studies. From single-center feasibility studies to large global multicenter randomized controlled studies, our team has got you covered. We are confident in our ability to deliver the results you need to take your medical device to the next level. You can trust us to provide you with the best service possible and help you achieve your desired outcomes in:
