Compliance Specialist
Are you looking for support in the implementation of the latest pharmaceutical and/or medical device regulations? At QbD, we can offer you a complete solution with the help of our compliance specialist team.
We can support you in the entire product lifecycle, from research to post-authorization activities. Find out more about our compliance specialist services below.
What is a Compliance Specialist?
As a life science organization (pharmaceuticals and/or medical devices), you need to be compliant with the latest applicable standards to keep your marketing authorization status. This is important to guarantee the safety and efficacy of your products.
Noncompliance can lead to major sanctions by regulatory health authorities (i.e. warning letter, withdrawal of marketing authorization), reputational damage or financial losses.
Due to the heterogeneous regulatory network, different countries and regions will have specific standards. Due to this variety and the changing industry environment, companies can face certain challenges (e.g. resources, competences) to implement these new standards in their current processes.
QbD’s compliance specialists can offer you support and guidance to maintain the quality compliance level of your company and to assure the quality, safety, and efficacy of your products.
Why QbD Group?
QbD can ensure that your company is aligned with current and upcoming Health Authority standards. This will allow you to react to market demands in a timely manner and in compliance with current regulatory obligations.
Furthermore, we can help you to increase your “first pass” audit success rate by supporting your continuous improvement projects and by preparing your site for health authority inspections.
We offer compliance support from the research/development phase to marketing authorization application and post-authorization activities. We have experts in:
- Good laboratory practices (GLP)
- Good clinical practices (GCP)
- Good manufacturing practices (GMP)
- Sampling and testing services
- Good distribution practices (GDP)
Our compliance specialists can provide day to day compliance management. Here you can find a non-limited overview list of our support capabilities:
- Audit readiness preparation (for internal and external purposes)
- Execution of gap assessments
- Risk-based remediation approach and CAPA plan
- Project management (improvements, observation follow-up)
- Quality training and coaching of your staff
- Quality issue investigations
- Change control processes
- Trending of quality KPIs
FAQ
- Failure to follow procedures and/or records
- Failure to detect correct root cause (deviation and CAPA investigations)
- Failure in laboratory controls
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) aims to harmonize guidelines to ensure that high quality medicines are developed worldwide
Contact us
Contact us for more information or request a free, no-obligation proposal.
