A comprehensive scientific and regulatory advice in every step of the product lifecycle can help our client’s device a plan for faster approvals. After approval of products you need to remain compliance with all the regulatory requirements (eg, post-approval process, pricing terms, variations, renewals) to keep the product in the market.
A strategic procedure to the Product lifecycle is also necessary to maximize the potential of the product and target the potential Market opportunities.
Medspero Pharma Group's expert regulatory consultants, acting as an extension of your team, bring a deep understanding of effective lifecycle management and the knowledge to offer a complete regulatory solution for your product when marketed in the GCC & MENA region. We can collaborate with your team to provide
- Regulatory advice
- Services for liaison with health authorities
- Applications for variations, line extensions, and renewals
- Post-authorization commitments are supported.
- Updates/translations of product information (PI)
- Artwork reviews
- Catalog text and local regulatory database management.