Individual Projects

 

If you have an idea in mind but are not quite sure how to execute it we can help with the regulatory strategy that will take your business where you want. We can classify your product (generic, hybrid, full application, etc), choose the best submission scenario (DCP, national, MRP, parallel submissions in different territories) and guide you through the submission phase. We will communicate with the agencies and always keep you in the know on what’s happening.

 

We can assist with a range of regulatory activities including:

 

  • Initial MA application
  • Dossier Review / Gap Analysis
  • Liaison with regulatory agencies to secure a submission slot
  • Creation of Module 1 including risk management plan (RMP)
  • Assistance with compiling Modules 2-5
  • eCTD Publishing
  • eCTD conversion/baseline submission
  • Preparation of SmPC, PIL and labelling

 

Regulatory Strategy

 

Do you know where you want your business to go to, just need help on how to get there?

We would be delighted to work with you on a regulatory strategy.

We enjoy building excellent relationships and providing practical solutions. We are both personal and transparent. As Panacea offers regulatory affairs and Pharmacovigilance services our regulatory team is able to act as a natural extension to your Pharmacovigilance team; whether this is in-house, or outsourced.

 

Workload Overflow & Continued Support

 

If you need sporadic support to help your busy RA department, we will be delighted to help.

 

Product Information Maintenance

  • Maintenance of SmPC, PIL and labelling
  • Maintenance of risk management plans

 

Article 57 (XEVMPD) Maintenance

 

Preparation & submission of variations

 

Renewals, extensions, transfers & withdrawals

No product or client is the same, so why should our services be? In Panacea we truly believe in a better way to do things and will take the time to understand your needs and requirements. We can be as little or as much involved as you wish. No task is too small and no challenge is too big.

 

Training

 

If you’re not looking for consultancy and would rather train your own team? We can provide a bespoke training solution that fits all of your needs.

BREXIT PREPARATIONS

We’re currently advising a number of clients in relation to navigating Brexit in both a ‘deal’ & ‘no deal’ outcome. Contact us to find out how we can help you.

or call +44 1624 672777