Regulatory Support
Regulatory Support: Elevating Compliance, Empowering Success
- Comprehensive Documentation for Product Registration
Our regulatory experts specialize in preparing comprehensive and compliant documentation, facilitating a seamless registration process for your products.
- Dossier Preparation for RX Products: From Concept to Compliance
From Concept to Compliance
We excel in crafting dossiers from scratch, meticulously meeting all regulatory requirements. Our commitment extends to guiding your RX products seamlessly from concept to compliance, with an unwavering dedication to quality. Additionally, we provide rigorous stability tests tailored for dossier registration, ensuring not only compliance with regulatory standards but also the sustained longevity and effectiveness of your products in the market.
Global Compliance
Prohibited Substances Screening for Global Compliance
To guarantee global compliance, we conduct thorough screenings for prohibited substances in each country. This includes an in-depth analysis of local laws and regulations, providing you with a robust foundation for product development and market entry.
Private label manufacturing
Having a manufacturing facility for therapeutic oral solid medicines with a current anual of 3.5 billion tablets and capsules per year makes us one of Europe’s largest manufacturing GMP pharmaceutical facilities.
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