We evaluate information and material to ensure that it is complete and of suitable quality to be submitted to the authorities, prepare the requirements for submissions in CTD, NeeS and eCTD format based on Authorities requirements and regulations and will provide a Compliance Services that Create Operational Excellence including compliance evaluation, critical issue remediation and resolution, risk assessment analysis, supporting system design and deployment, gap analysis, publishing, and much more. Yet helping clients meet regulatory obligations is only the beginning of our services. On the path to regulatory compliance, we identify areas where operations and processes can be improved with simple, cost-effective solutions, ensuring maximum efficiency and quality along with product and regulatory integrity.
Our full time expert team is able to deal with projects of any scale or length, whether on-site or remote, domestic, international, or multinational.
We submit and follow-up the Registration files until getting the approval for the following:
- Drug products; NCE, Biologics Radiopharmaceuticals, generics and OTC products
- Herbal products and Food supplements
- Listing products e.g. energy products
- medical devices
- Food products
- Veterinary products
- Renewal of Marketing Authorization