Regulatory Affairs & Submissions
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.
Market Access Strategy
Established in 1997, Omega CRO leverages decades of experience to provide boutique consultancy services in market access, offering all necessary components under one roof. Known for innovation and comprehensive alternatives, Omega CRO ensures effective strategies for market entry and growth in the healthcare sector.
Health Technology Assessment (HTA)
Health Technology Assessment (HTA) is a vital process used to evaluate the clinical, economic, and societal impacts of health technologies. Omega CRO specializes in providing comprehensive HTA services that assist stakeholders, including policymakers, healthcare providers, and payers, in making informed decisions about the adoption and use of new health technologies.