Quality Management System (QMS) Development
Our comprehensive Quality Management System (QMS) Development services are tailored specifically for the dynamic and highly-regulated pharmaceutical and biotech industry.
We understand the critical importance of maintaining the highest standards in quality, compliance and efficiency within your operations. That’s why our experienced team is dedicated to supporting you in developing robust QMS solutions that ensure regulatory compliance, streamline processes and enhance your overall performance.
Our expertise covers:
- GxP regulation (GCP, GMP, GVP, GLP ...)
- EU regulations and standards
- ISO 9001, ISO 13485, ISO 22716
- US FDA 21 CFR
- Other international regulations (Japan, Australia, China and more)
Trusted by top-tier teams worldwide
Our QMS Development process:
- Needs assessment – Identify quality management requirements, compliance goals and challenges.
- Gap analysis – Review discrepancies between current practices and regulatory standards.
- Authoring documentation and SOPs – Write or remediate SOPs for clarity, implementation and compliance.
- Validation and testing – Ensure systems function as intended and meet audit-ready validation standards.
- Risk management – Apply QRM tools like FMEA and HACCP; align with ICH Q9 and CAPA processes.
- Training and change management – Train teams, manage cultural transitions and SOP adoption.
- Ongoing support and maintenance – Provide continual compliance monitoring, updates and CAPA implementation.
FAQs
At Apotech, we offer full transparency on our Quality Assurance services. We aim to make the process as simple to understand as possible and are always on hand to answer any questions you might have.
Here are some of the questions we get asked most often.
Yes, we have an amazing team of consultants who work with us to perform local activities such as batch release or authoring SOPs in local languages.
As we understand each country's specificities, we can supply you with the right qualified person, according to the local regulations required.
Featured case studies
GMP QA Consulting
GMP QA Consulting Introduction Global API Manufacturer The client was an API manufacturer, with a need for some support to cope with a deviation backlog. Apotech consultant: Two QA Consultants, with backgrounds in sterile devices. Types of Audits GMP Tools: Ishikawa, 5M Audit Locations Europe Scope of work Under the QA director supervision, our consultant…