REGULATORY AFFAIRS

RegulatorY AffaIRS FrEELANCE CONSULTANCY AND HOW IT BENEFITS YOUR COMPANY

RAQA serves companies that:

  1. Need help to update their Products regulatory documents to comply with the Markets regulations
  2. Need help to update their Procedures to reflect regulatory compliance
  3. Have started new processes and need assistance testing them and documenting validity
  4. Have received a non-conformity from a Notified body and need extra help to solve the issue.
  5. Assist in coordinating Global projects to ensure that the proejct is completed successfully on time. 

RAQA can assist your regulatory compliance transition when you need help. Your company can receive help even if it is just for smaller compliance projects that need to be done to fulfil regulatory standards.

By doing this, RAQA can help you minimise the number of unfinished projects and complete them without disrupting normal operations.  

RAQA provides Regulatory Affairs services in

1. Medical Device product registration in Latin America, the Middle East, Africa and most Asian countries.

2. Vigilance / Complaint handling processing including clinical evaluations, responsibility for reporting to Authorites and corresondance with questions from Authorities.

3. Failure trending and clinical consequences data analyses for Post-marketing surveillance.

4. Liaison with international distributors to ensure regulatory compliance and completion of product registrations. 

5. Translation of documentation from Danish to English

 

How to achieve this

RAQA can help your company comply to regulatory regulations and the approach will often be decided together with your company. This could include:

  1. Prioritising the projects that need to be done and giving an approximate timeline.
  2. Specifying methods, goals and standards of each task.
  3. Draft and implement the chosen path. Approval is given from the company before continuation.
  4. Executing the plan and delivering the finished product.
  5. Providing follow-up support as needed.

Let’s discuss your needs and make a solution together.
Contact Laura Rossing on:

+45 40 12 99 69​

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