Altiora Türkiye
Regulatory Affairs & Market Access
Guiding organizations through complex regulatory environments to achieve compliance, accelerate market entry, and expand business opportunities.
Market Access
Partnership in Türkiye
We manage and coordinate your regulatory and market access processes, ensuring full compliance and efficient navigation of Turkish health authorities.
Regulatory submission planning and documentation coordination
Market access strategy and pricing process support
Timeline tracking and authority communication management
Compliance-focused process structuring
Risk identification and control point definition
Outcome
Faster regulatory progress, reduced compliance exposure, and improved visibility across approval processes.
Regulatory Affairs Services
Our Regulatory Affairs Department provides end-to-end support for pharmaceutical, biotechnology, food supplement and medical device companies operating in highly regulated markets.
We ensure full compliance with national and international legislation while enabling seamless market entry and sustainable lifecycle management.
Company Establishment & Ministry Procedures
We manage all regulatory steps required to establish your company under the Ministry of Health. Services include:
- Preparation and submission of official applications
- Full follow-up and communication with authorities
- End-to-end process management until approval
Marketing Authorization Transfer
Comprehensive management of Marketing Authorization (MA) transfer projects. Scope:
- Preparation of transfer dossiers and official documentation
- Coordination with authorities and all relevant stakeholders
- Execution of the complete transfer process
Technology Transfer (Manufacturing Site Changes)
Regulatory expertise for product and manufacturing technology transfers.
Services include:
- Documentation review and compliance alignment
- Coordination between sending and receiving manufacturing sites
- Support throughout the entire transfer lifecycle
Variations Management (Type IA, IB, II)
We ensure full compliance for all post-approval changes.
Our support covers:
- Gap analysis of variation dossiers
- Translation of impacted CTD modules
- Identification of applicable guideline sections and variation categories
- Preparation of variation dossiers according to regulatory guidelines
- Electronic application submission (upon request)
SmPC & PIL Preparation
We develop and update SmPC and PIL documents with scientific and regulatory precision.
Services include:
- Updating SmPC/PIL based on global reference documents
- Preparing SmPC/PIL for generic products aligned with originator reference
- Translation and back-translation services
- Alignment with global medical and regulatory teams
GMP Inspection Applications & Management
Expert support for all GMP inspection application types.
Scope of services:
- Gap analysis of GMP dossiers
- On-site inspection application preparation
- Risk-based and dossier-based inspection applications
- On-site support during GMP inspections
- Preparation of responses to deficiency letters
Pharmaceutical Pricing Applications
Strategic pricing support aligned with Turkish regulations.
We provide:
- Calculation of ex-factory prices based on international reference pricing
- Identification and assessment of reference countries
- Validation of lowest reference price
- Currency conversions using official fixed Euro/TL rates
- Development of pricing scenarios for market access strategies
Food Supplements Applications
End-to-end regulatory services for food supplements.
Services include:
- Preparation of application dossiers
- Pre-notification procedures
- Compliance review of product composition
- Claim compliance assessment and reporting
- Management of notification and approval processes
- Ministry opinion applications on active ingredients
Medical Device Applications
Regulatory registration and product compliance services for medical devices.
Scope:
- Company registration with Provincial Health Directorates
- Identification of documentation based on device classification
- Registration of products and certificates in TITUBB
- Full process tracking and coordination
What We Do
Altiora provides specialized regulatory affairs and market access services for pharmaceutical companies entering or operating in Türkiye. We guide international firms through the full lifecycle of product registration, pricing, reimbursement, and market entry, ensuring compliance with Turkish regulations while accelerating commercial access.
Our team bridges local regulatory expertise with global pharmaceutical standards, delivering end-to-end support for successful market operations.
Problems We Solve
Navigating Türkiye’s drug registration, licensing, and compliance requirements can be challenging for foreign companies.
Pricing, reimbursement, and market entry procedures often involve multiple stakeholders and lengthy timelines.
Understanding local healthcare regulations, payer systems, and stakeholder expectations requires specialized knowledge.
Failure to meet regulatory requirements can result in delays, fines, or lost market opportunities.
Our Approach
End-to-End Regulatory Management
From initial product registration to ongoing compliance, we manage the entire regulatory process.
Market Access Strategy & Execution
We design pricing and reimbursement strategies that align with local payer requirements and commercial objectives.
Stakeholder Coordination
Engage and manage all relevant authorities, payers, and partners to ensure smooth market entry.
Compliance & Risk Mitigation
We ensure that all submissions, approvals, and reporting are fully compliant with Turkish regulations and international standards.
Deliverables
• Product Registration & Licensing
Prepare and submit dossiers to the Turkish Medicines and Medical Devices Agency (TITCK) for approval.
• Pricing & Reimbursement Strategy
Develop strategies for competitive and compliant pricing and reimbursement.
• Market Access Support
Facilitate engagement with payers, healthcare authorities, and key stakeholders.
• Regulatory Compliance & Reporting
Monitor regulatory requirements, renew licenses, and maintain up-to-date compliance documentation.
• Risk Management & Advisory
Assess regulatory and market access risks, provide mitigation strategies, and ensure smooth market entry.
• Post-Market Support
Support for pharmacovigilance, reporting, and product lifecycle management.
Regulatory approval and market access are critical for pharmaceutical success in Türkiye. Missteps can lead to delays, lost revenue, or compliance issues.
Altiora ensures that pharmaceutical companies navigate this complex landscape efficiently, mitigating risks while maximizing speed to market and commercial success.
Example Scenarios
A global pharmaceutical company wants to launch a new product in Türkiye.
We manage the registration, licensing, pricing, and reimbursement process end-to-end.
Market entry requires stakeholder engagement.
Altiora coordinates authorities, payers, and partners to streamline approvals.
Regulatory compliance is unclear or risky.
We ensure full compliance with Turkish laws and international best practices, minimizing delays and risks.
Start your journey with Altiora !
Elevate your standards and redefine success. Our dedicated team is here to provide the tools you need for a seamless professional journey.