Regulatory Services
At Advik, we understand the complexities of navigating the regulatory landscape in the healthcare industry. Our dedicated Regulatory Services team offers comprehensive support to ensure your products meet all necessary compliance standards, facilitating a smoother path to market entry.
Specialized regulatory consultancy
We provide registration and regulatory consulting services for food supplements, cosmetics and healthcare products and devices. Our regulatory affairs experts maintain ongoing liaisons with regulatory authorities, manage our clients’ dossiers, process a large number of marketing authorizations on behalf of our clients and safeguard their interests.
Regulatory services we provide include:
Pre-registration
- Regulatory feasibility assessment
- Labeling requirement assessment
Registration
- Dossier preparation
- Compliance check
- Product sample submission
- Dossier submission
- Registration follow-up and monitoring
- Regulatory approval
Post-marketing
- Marketing Authorization (MA) holding,
- Maintenance and transfer
- Variations (minor and major)
- Renewal
- Advertising compliance check
Specialty services
- Technical services
- Operational services