Preparation of Submissions

We can produce all or part of your regulatory submission. We can work as an integral part of your team either working remotely or on your site. Submissions can be made direct to agency if required.

Marketing Authorisation Applications
We have extensive experience of producing MAAs and apply our professional and scientific capabilities to produce high quality submissions. We have experience of submissions through MRP, DCP and National procedures. The majority of our applications are submitted electronically.

We are particularly experienced in Module 3 and Quality Overall Summaries

Post approval submissions and life-cycle management
We can prepare and submit variations to marketing authorisations.

We have experience with legal category change (POM to P and P to GSL), and can help with change of ownership, line extension and "piggy back" applications.

Active Pharmaceutical Ingredients
We can prepare and submit Active Pharmaceutical Ingredient Master Files and submissions for EDQM Certificates of Suitability.

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