Begüm ÇİÇEK

I provide professional expertise in the field of dietary supplements and herbal medicinal products, supported by hands-on field experience and up-to-date regulatory knowledge. I support companies in building sustainable structures aligned with their quality, regulatory, and operational objectives across areas including CTD / eCTD dossier preparation, national and international regulation, technical documentation, microbiological environmental monitoring under GMP, and quality management systems.

In line with Aktiv360’s integrated consultancy approach, I consider regulation and quality not merely as documentation requirements, but as living, dynamic systems embedded throughout the organization’s entire operational structure. With this perspective, I develop solutions that are aligned with real-life field conditions and function effectively not only during audits but also in daily operations, aiming to establish systems that are both regulatory-compliant and operationally feasible.

I have strengthened my technical expertise in CTD  processes at an academic level through the CTD – Module 3 Regulation Training provided by Hacettepe University. I offer end-to-end support to companies in the establishment, integration, and sustainability of quality, food safety, occupational health and safety, and environmental management systems, particularly ISO 9001, ISO 22000, ISO 45001, and ISO 14001.

Areas of Expertise :
- CTD / eCTD dossier preparation
- Product development and regulatory compliance in dietary supplements
- National and international regulation process management
- GMP-compliant microbiological environmental monitoring
- Technical documentation and audit-ready infrastructure setup
- Quality and regulatory oversight throughout the product lifecycle
- ISO 9001 Quality Management System implementation and integration
- ISO 22000 Food Safety Management System applications
- ISO 45001 Occupational Health and Safety Management System
- ISO 14001 Environmental Management System
- Regulatory-compliant internal quality control and risk management systems

My working approach aligns with Aktiv360’s “systems that work in the field” philosophy and goes beyond merely meeting technical requirements. I prioritize working closely with internal teams to integrate quality and regulatory requirements into business processes and ensure their practical implementation. By simplifying theoretical obligations through practical application, I focus on enabling teams to internalize processes and embed systems naturally into the organizational culture.

Across all processes—from microbiological environmental monitoring to regulation and quality management systems my primary objective is not only to help organizations meet legal requirements, but also to contribute to the establishment of audit-ready, quality-driven, and long-term sustainable structures.