MeddiQuest Limited - Regulatory Affairs Management

Our Services

How we work

Where possible, we always offer to work to a contract: an agreed price for an agreed deliverable, that means that unlike with a conventional consultancy, who work on time-chargable basis, you know the financial extent of your commitment at the outset. More importantly, it our way of sharing the risks inherent in the regulatory environment with our customers, and stressing our commitment to work in partnership with our customers.

We believe in tailoring every contract to our customers needs, hence we do not have standard products. However, there are a number of elements required by many customers, for example:

• Monthly or Bi-Monthly Regulatory Updates via e-mail
• Training Session on aspects of U.S. or E.U. Regulations
• Quality System Training

E.U. Regulations

We specialise in assisting international and European customers to meet E.U. Regulations. Typical Activities include

• Determining appropriate regulatory strategy
• Training, Coaching, Management Development
• Selection of NB
• Negotiating with CA's and NB's
• Combination Product Classification
• Designing and Running Quality Systems
• Internal and Vendor Audits
• EU Authorized Representative for International Customers
• Sub-Contract: Complaints Handling, Surveillance, Marketing and Sales

U.S. Regulations

We specialise in assisting international and domestic customers to meet U.S. Regulations. Typical Activities include

• Determining appropriate regulatory strategy
• Product Listing and Establishment Registration
• Produt Submissions: 510(k), PMA, PDP
• Preparing for and managing FDA Inspections
• Designing and Running Quality Systems to meet GMP/QSR regulations
• US Agent Service
• Sub-Contract: Complaints Handling, Surveillance, Marketing and Sales

Rest of the World

We have specialist expertise in dealing with regulations in South and South East Asia, Australia and New Zealand, Canada, Non-EU/EFTA European Countries. Because of the diversity of regulations and systems, please contact us for details.

email us at info@meddiquest.com

Uploaded April 21, 2006
Last updated January 19, 2016
MeddiQuest Limited: Incorporated in England under number 4226188 at Quest Science PE2 5XS