Regulatory Affairs & Submissions
End-to-end regulatory leadership covering submission strategy, Ethics Committee and TİTCK pathways, and lifecycle compliance to keep programs inspection-ready and on schedule.
Comprehensive Regulatory Affairs & Submissions
End-to-end regulatory leadership covering submission strategy, Ethics Committee and TİTCK pathways, and lifecycle compliance to keep programs inspection-ready and on schedule. Our experienced team works closely with sponsors to ensure every aspect of the study is planned with precision, from initial concept through to regulatory submission.
Assess
Evaluate objectives, feasibility, and regulatory landscape
Design
Develop protocol, statistical plan, and operational framework
Validate
Expert review, risk assessment, and stakeholder alignment
Execute
Initiate with confidence — fully documented and approved
Sub-Services
Explore each specialized area within Regulatory Affairs & Submissions.
Regulatory Affairs
A full-scope regulatory service aligning global development plans with local authority requirements from first submission through...
8 key featuresEthics Committee and MoH TİTCK Submissions
Structured management of Ethics Committee and MoH TİTCK submissions with Turkish localization, dossier quality control, and active...
5 key featuresMarket Access Strategy
Boutique consultancy services providing effective strategies for market entry and growth in the healthcare sector.
5 key featuresHealth Technology Assessment (HTA)
Comprehensive HTA services evaluating clinical, economic, and societal impacts of health technologies.
5 key featuresWhy Choose Omega for Regulatory Affairs & Submissions?
29 Years Experience
Designing and planning trials since 1997 — across all major therapeutic areas.
Regulatory Expertise
Deep knowledge of TİTCK, EMA, FDA, and Health Canada requirements.
Integrated Approach
Strategy, statistics, regulatory, and operations under one roof — no handoff gaps.
What You Receive
From strategy through delivery, every engagement is structured for predictable timelines, compliant execution, and measurable outcomes.
Dedicated Lead Team
Single-point scientific and operational ownership with clear escalation paths and weekly governance updates.
Authority-Ready Documentation
Submission-grade deliverables prepared with quality control checkpoints and audit-traceable versioning.
Risk-Led Planning
Proactive risk logs, mitigation plans, and milestone tracking to protect study continuity and budget integrity.
Cross-Functional Integration
Regulatory, medical, biometrics, operations, and quality teams aligned in one integrated delivery framework.
Ready to Get Started?
Contact our team to learn how Omega CRO can support your clinical research needs.