NEWRACS
Regulatory strategy
- • Analyze the regulatory status of products’ range and entire product portfolio.
- • Determine whether products are truly marketable in terms of regulation and whether their documentation and basis of data reflect the latest scientific findings.
- • Study the regulatory requirements and prepare the product registration files.
- • Decide the appropriate regulatory path per product category.
- • Apply and follow up for the registration of the product in the specified authority.
Regulatory Process Management
- • Manufacturing Sites and MAH Companies registration
- • Compile information and review files for corrections.
- • Application process management (Product registrations with the Regulatory Authorities).
- • Follow up with regulatory authorities to overcome any regulatory issues and challenges.
- • Responding to requests and queries of regulatory authorities.
- • Provide Labelling, artwork and translation guidance to comply with UAE guidelines.
- • Follow up for all required quality control and laboratory tests by authorities.
- • Act as local representative in front of local authorities.
Agency representation
- • Classification/registration process with regulatory authorities.
- • Import permit process.
- • Invoicing for end user.