REGULATORY & CONSULTING
Regulatory Affairs
Cosmetic products must comply with strict regulations to be placed on the market. At inovapotek, our Regulatory Affairs team ensures that your products fully meet all applicable EU cosmetic regulations. We navigate complex regulatory landscapes to ensure EU market access for your products, allowing you to focus on innovation and business growth.
- Preparation of Product Information File according to EU Regulation (EC) No 1223/2009
- Preparation of Cosmetic Product Safety Report according to EU Regulation (EC) No 1223/2009
- Safety assessment according to MoCRA
- Preparation/review of labels according to EU Regulation (EC) No 1223/2009
- Formula review according to EU Regulation (EC) No 1223/2009
- Claims substantiation report
- Notification to EU authorities (CPNP)
Consulting Services
Bringing a product or project to life is a complex journey, with many challenges along the way. At inovapotek, our daily work across research, development, and regulatory processes has given us the expertise to guide you through every step. Our team offers specialized consultancy for new ingredient development, acting as the strategic bridge for biotech and chemical companies, transforming raw molecules or extracts into high-value, market-ready dermocosmetic assets.
Scientific & Data Assessment
- Comprehensive review of scientific literature and sponsor data to identify mechanisms of action, safety profiles, and dermocosmetic potential
Market Positioning & Benchmarking
- Competitive landscape analysis to differentiate your ingredient from existing actives and define strategies
Application Potential
- Expert guidance on feasible formulations, product types, and optimal usage concentrations
Regulatory & Safety Strategy
- Early-stage advice on safety assessments and the specific requirements needed for global compliance
R&D Roadmap Definition
- A tailored, step-by-step development plan, including prioritized in vitro, ex vivo, and clinical testing to substantiate your efficacy claims
Scientific writing & support
- Developing innovative methodologies in partnership
- Scientific papers, posters, and presentations
- Sales and marketing material
Training Sessions
Navigating product development is a complex field that requires expertise across many different areas, from scientific research and formulation to regulatory compliance, project management, and marketing and sales. At Inovapotek, our team designs training sessions to bridge critical knowledge gaps, providing practical, expert-led guidance that empowers your team, strengthens skills, ensures compliance, and drives successful outcomes.
Market & Innovation
- Cosmetic and personal care trends: insights and opportunities
- How to identify market gaps and emerging product concepts
- Innovation scouting and ingredient selection
Scientific Communication
- How to pitch your ingredients effectively
- Writing compelling scientific papers, posters, and presentations
- Translating scientific data into marketing and sales materials
Claims & Marketing
- How to boost your product claims
- Substantiation of claims: dos and don’ts
- Communicating benefits without regulatory risk