Expert Regulatory Support for Global Markets
Navigating the complex landscape of international compliance is a critical phase of new product development. At AKTO, our regulatory and documentation services ensure that your cosmetics and food supplements meet all necessary legal requirements. We simplify the path to market, allowing you to focus on brand growth while we handle the technical dossiers.
Our dedicated team provides comprehensive support tailored to your target regions, including the EU, UK, and Ukraine. We bridge the gap between R&D related activities and final market access, securing your product's compliance every step of the way.
Comprehensive Documentation Services
We offer a full suite of regulatory documentation designed to support your manufacturing services and product launches. Our experts meticulously prepare and review all necessary files to ensure strict alignment with current international regulations.
- Product Information Files (PIF): Complete compilation in accordance with EU Regulation (EC) No 1223/2009 for cosmetic products.
- Cosmetic Product Safety Reports (CPSR): Detailed safety assessments conducted by qualified toxicologists to ensure consumer safety.
- Labeling & Claims Review: Verification of ingredients lists, allergens, and marketing claims for full global compliance.
- Notification Assistance: Support with CPNP (EU) and SCPN (UK) product registrations before market placement.
- Safety Data Sheets (SDS): Preparation of standardized documents detailing chemical properties and safe handling procedures.
- Technical Dossier Compilation: Structuring comprehensive technical files required for food supplements and specialty formulations.
- GMP Certification Support: Documentation alignment for ISO 22716 (GMP) and ISO 22000 (HACCP) audits.
- Export Documentation: Generation of Certificates of Free Sale and other essential documents for international distribution.
Integrating Compliance with Formulation
Regulatory compliance must be integrated from the very beginning of formulation. By aligning our regulatory checks with our Formulation & R&D processes, we prevent costly delays. This proactive approach ensures that every ingredient and claim is substantiated before transitioning into full-scale Private Label Manufacturing.
Whether you require Cosmetics Documentation, specialized Supplements Documentation, or thorough Labels & Claims Review, our regulatory team is equipped to deliver precise, audit-ready materials.