Regulatory & Ethics Submissions & Safety
core values
At Omega CRO, we prioritize integrity, excellence, and client-centricity in everything we do. Our commitment to these values ensures that we deliver transparent, high-quality, and innovative research solutions tailored to our clients' needs.
Regulatory Affairs
Regulatory Affairs is a critical service within the pharmaceutical and biotechnology industries, ensuring that clinical trials and products comply with all applicable legal and ethical standards. This service involves managing interactions with regulatory bodies, preparing and submitting documentation, and providing strategic guidance to navigate the complex regulatory landscape.
Ethics Committee and MoH TİTCK Submissions
Omega CRO provides expert guidance and support for Ethics Committee and MoH TİTCK (Turkish Medicines and Medical Devices Agency) Submissions, ensuring that all clinical trials are ethically sound and compliant with local and international regulations.
Pharmacovigilance and Safety Reporting
Pharmacovigilance and Safety Reporting are vital components of clinical research and product lifecycle management, focusing on the detection, assessment, understanding, and prevention of adverse effects and other drug-related problems. These services play a crucial role in ensuring patient safety and maintaining the therapeutic efficacy of products throughout their lifecycle.
Post-Market Surveillance (PMS)
Post-Market Surveillance is an essential component of the lifecycle of medical products, ensuring their safety and efficacy after they have been launched in the market. Omega CRO’s PMS services are designed to systematically monitor the performance of medical devices and pharmaceuticals once they are available to the public. This ongoing monitoring helps in identifying any potential adverse effects or safety concerns, ensuring compliance with regulatory requirements, and providing valuable insights for future product development.