Quality and Regulatory Consulting
BBI Solutions can now offer an extended range of quality and regulatory consultancy though our preferred partner, CHIARA Regulatory Consultancy Services Ltd, further enhancing our end-to-end service offering.
Our partner, CHIARA, is dedicated to guiding medical device companies, regardless of size, through the ever-changing and complex global regulatory medical device environment.
CHIARA offers a flexible consultancy support service which is tailored to suit the client, providing a clear plan and a hands-on approach to implementation. CHIARA has experience of the development, validation, manufacturing, registration and post-market activities for a wide range of in vitro diagnostic professional and home use medical device tests.
This has included blood grouping reagents, HIV tests and a wide range of different women’s health, infectious disease, drugs of abuse and cardiac marker tests.
Experience gained in the development, validation, manufacturing, clinical and regulatory submission activities associated with many different tests using lateral flow technology makes for a strong partnership between BBI Solutions and CHIARA.
Lesley Paice, CHIARA’s Principal Consultant, supports a number of medical device companies with the implementation of IVDR/MDR, including assisting with classification, gap analyses, compilation of technical documentation and changes to QMS documentation to facilitate the transition from IVDD/MDD to IVDR/MDR. Lesley also has experience of carrying out MDD Notified Body expert reviews for Class III sodium hyaluronate based medical devices and has received NB training in new IVDR and MDR requirements.
CHIARA has detailed knowledge of the regulatory pathways in the US with experience of successful 510(k) submissions and Biologics License Applications to the FDA, as well as participating in a number of successful FDA inspections. CHIARA also offers support to customers in global regulatory submission activities.
BBI Solutions and CHIARA can offer a number of different packages to suit clients' needs and requirements as follows:
|
Package |
Description |
|
1 |
Ad hoc regulatory or quality support for companies who have their own regulatory and quality staff and require only occasional external support. |
|
2 |
EU – Preparation of a regulatory strategy plan and preparation and submission of CE marking Technical Documentation. |
|
3 |
US – Preparation of regulatory strategy plan, support in FDA meetings, preparation and submission of 510(k) pre-market notification. |
|
4 |
ISO 13485 – Preparation of regulatory strategy plan, procedures and records required for ISO 13485 certification and support through stage 1 and 2 certification audits. |
|
5 |
21 CFR Part 820 – Preparation of regulatory strategy plan, procedures and records required for 21 CFR Part 820 compliance and assistance with FDA audit (if required). |
|
6 |
Custom regulatory support depending on the markets the customer wants to enter. Preparation of regulatory strategy plan documenting the tasks required for the required market entry including costs and timelines. |
Other submission types can be scanned and scoped on request
Further details of the services offered by CHIARA can be found on the website www.chiara-raqa.com.
Contact
Business Address: 60 Constitution Street, Edinburgh, EH6 6RR.
☎ 07909 983485
