Accelerate approvals with
shorter regulatory timelines

At Clicebo, we understand the need to mitigate risk and respond to crises promptly to break the deadlocks associated with non-compliance. From Clinical Trial submissions to market authorization, we offer a wide spectrum of services throughout Asia Pacific, Europe & United States of America. With total commitment to the success of your clinical development program, we focus on

Shortening

approval timelines

Accelerating

regulatory submission processes

Strengthening

quality measures

We are dedicated to serve you as your partner with total commitment to the success of your clinical development program. Our services can be used by pharmaceutical, biotechnology, device, diagnostic, and research organizations. Our goal is to mitigate risk and respond to any crisis quickly, so you avoid the headaches associated with non-compliance.

Our spectrum of services

Regulatory assessment, strategic support in global product development, marketing authorization applications, submission planning.

Common Technical Document compilation and technical writing (PMCF, CER, BER etc)

Product lifecycle management related to a clinical point of view (Periodic PADER submissions, ADE report submissions, Annual reports (for US) in addition to the review and compilation of the PSMF (for Europe)

Dossier preparation including the quality, efficacy safety and administrative information to Health Authorities across the globe.

Health audit and inspection assistance

Import/export permits for investigational product and biological samples

Handling medical inquiries adverse event reporting, preparing the medical review of adverse event reports, and periodic literature review

Health authority meeting support briefing documents, and health authority liaison