Bio Park, Broadwater Road
AL7 3AX Welwyn Garden City
United Kingdom
Phone: +44 1763 222-505
Fax: +44 1763 222-049
http://www.meddiquest.com
info@meddiquest.com
Company Profile
Our Services
How we work
We always 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 ad systems, please contact us for details.