Your Experts for Regulatory Solutions in Food Contact Materials and Pharmaceuticals
Integrate compliance proactively and turn regulatory challenges into opportunities for innovation, competitive advantage, and sustainable growth.
Jelena Dimitrijevic
Possessing a PhD in Chemistry and extensive experience in Regulatory Affairs across the pharmaceutical, chemical, and plastic packaging industries, this expertise enables effective guidance through complex regulatory frameworks. Regulatory strategy is leveraged as a core business enabler, transforming intricate regulatory requirements into practical, actionable solutions that deliver sustainable value and support long-term growth.
Our Professional Services
Regulatory Intelligence (RI)
- Facilitates informed decision-making to mitigate risks, accelerate market access, and ensure sustainability in the market.
- Enables organizations to anticipate regulatory changes and adapt proactively.
- Supports compliance by transforming complex data into actionable insights.
Regulatory Strategy
- Development of tailored regulatory strategies considering current regulations and their interactions (PPWR, GPSR etc.).
- Comprehensive project management for the implementation and monitoring of regulatory requirements.
- Integrates cross-functional collaboration.
- Adapts to changing regulatory requirements to maintain compliance and competitive advantage.
Implementation of Regulations
- A practical, tailored step-by-step guide for implementing new regulations.
- Conducting practical stuff training on regulatory topic.
Food Contact Materials (FCM) – Plastics
- Providing regulatory compliance – conducting gap analysis.
- Providing support in the preparation of a Declaration of Conformity (DoC).
- Reviewing regulatory documents, including supplier documentation and various statements such as PFAS under PPWR requirements, Bisphenols, etc.
- Effective supplier communication.
- Conducting practical training on diverse regulatory topics, customizable to the needs of organizations and supplemented with examples from practice.
Pharmaceuticals:
- Due diligence assessments.
- Preparation of registration dossiers (Modules 1–3).
- Life-Cycle Management.
