Regulatory Submissions

Empatec can prepare documents for all or part of your regulatory submission, including:

Marketing Authorisation Applications
We apply our extensive experience to produce high quality submissions. We have experience of submissions through MRP, DCP and National procedures.

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

  • Quality variations
  • Safety Variations to update product information in line with recommendations in Periodic Safety Update Reports (PSURS) or Company Core Data Sheets.
  • Legal category changes (POM to P and P to GSL) - UK "ARM" applications (Application to Reclassify a Medicine).


If required we can work as an integral part of your team either working remotely or on your site.

Our experienced consultants can support your regulatory submissions for a wide range of product types. Read More >

About Empatec

We are an experienced team of consultants with a track record of delivering results.

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Our Services

We provide advice to companies developing, manufacturing, marketing or licensing products.

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Sectors

Empatec works across all key pharmaceutical and healthcare sectors.

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Contact Us

Contact us today to discuss your current regulatory issues or to plan future requirements.

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