Quality Assurance & Regulatory Affairs | Excelya

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Excelya>Regulatory Affairs

A strong formula for submission

Regulatory Affairs

Our Regulatory Affairs department provides a clear path to regulatory approval by ensuring confident, accurate and timely document submissions. Our regulatory team has up to 20 years of experience across all therapeutic area, phases and industries. We support marketing authorisation application across the product lifecycle, including market access and promotional material compliance.

We leverage flexibility, experience in multidisciplinary projects, excellent relationships with health authorities and deep knowledge of the regulatory environment to ensure that your submission is ready for review and timely conclusion.

Regulatory Affairs

What we deliver

Our clinical trial services take you from initiation to follow-up to completion. They include:

Development: Core documentation regulatory review & submission strategy
Submission/review: EU planning, EU CA/EC submission, answer to CA/EC questions
Activation: Public registry registration, FVLP
Conduct: Amendment follow-up, public registry update, completion

Our marketing authorisation and post-marketing authorisation services include:

Μarketing Authorisation Applications for medicinal products (DCP/MRP/National Procedures)
Local activities following Centralised Procedures
Maintenance of the Marketing Authorisations, Variations and Renewals
Transfers of Marketing Authorisations
High quality translations of the Summaries of Product Characteristics, Labeling and Patient Leaflet
Effective collaboration with the authorities and follow-up of submissions, to ensure timely conclusion of the procedures
Publishing in eCTD
Pricing and Reimbursement applications and consultancy
Regulatory review of artworks/packaging material
Regulatory review of promotional material
Regulatory Intelligence
Consultancy services on local regulatory provisions and requirements.
Notifications/Registrations and consultancy services for medical devices, food supplements, cosmetics and biocides
Training in Regulatory Affairs

How can we help support your trial?

Submit your request



		
		













































    
        
    







 




    
        
            
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