Regulatory Affairs

The only constant in pharmaceutical regulatory affairs is that guidance and best practices will continue to change and evolve over time. In addition to providing a wide range of regulatory services, CPS is also actively analysing the latest pharmaceutical drafts and adopted guidelines from the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA) in cooperation with the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) as well as individual country specific updates.

 

MRP/DCP/National filings & MA Holding

We can submit your registration documentation to any member state in the EU in eCTD, NeeS or CTD format. We can manage the procedure from the beginning till the successful MA issuing. Our company can also be the applicant and/or the future MAH for your submissions during the entire registration procedure.

 

Life cycle management

Our Regulatory Affairs Managers and Officers can support you in the maintenance of the existing marketing authorizations. They can prepare and submit the variations/renewals on behalf of your company.

 

Readability testing

Our specialists can reformat your PILs, SPCs into the QRD and provide you the consultation with the patients.

 

Translations in all languages

We can ensure the high quality translations of your regulatory affairs/medical/marketing documents into all languages.

 

Labelling, DTP artwork

Our team can assist with your global labelling needs with original artwork/specimen creations through to adding Braille.

 

Dossier preparation

The group of our Regulatory Affairs Specialists will help you to complete the dossier for the EU submission. We can provide you the eCTD or NeeS fomat.