Marketing Authorization Maintenance

After obtaining Marketing Authorization (MA), a pharmaceutical product is permitted for commercial use. Nonetheless, maintenance requirements must be met in all controlled locations.

To continue to have Marketing Authorization, the holder must:

  • 01

    Update work to ensure the authorized dossier is valid

  • 02

    Having pharmacovigilance procedures in place will help with safety monitoring issues.

  • 03

    Implement and maintain quality management / assurance systems to accommodate advancements such as alterations to the product's manufacture and pertinent alterations to the company's settings.

  • 04

    Respond as necessary to renewal requirements

  • 05

    Large product portfolios, diverse worldwide markets, fluctuating regulatory landscapes, and stakeholder expectations can further

  • 06

    Raise the post-approval phase's complexity, unpredictability, and intensity.

Changes in technology and legislation necessitate constant revisions to systems, documentation, and contracts. As a result, time and resources may be constrained, causing the development of new products to suffer.

We provide worldwide regulatory solutions that encompass the complete product lifecycle. Our solutions consist of fundamental services that are customized to meet each of your specific needs. Extensive knowledge of program management is a critical success factor for our service offerings.

We’d love to hear more about your needs

Even if you are still in the planning stages of your project, you are more than welcome to submit a request to us. We can assist you with a quotation or create a proposal for you based on the minimum of information you can provide.

RFP - RFI

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CEBIS Interantional

Romania- Helios Business Center (HBC),
47 Bd. Theodor Pallady,
Bucharest, Romania