Ensure your quality assurance is both strategic and effective by partnering with our QA specialists.
Strategic and efficient quality assurance is essential to an organization’s continued success. This applies to all areas, whether you are developing new pharmaceuticals or processes, or carrying out improvement projects.
Maintaining strategic and financial control whilst meeting high quality and regulatory standards is both challenging and crucial for companies.
We offer a wide range of quality services, covering pharmaceuticals, medical devices, and cosmetics. We help you to stay compliant with the latest regulations whilst meeting project and business goals with an optimal use of resources.
Our Quality Management team is made up of quality assurance specialists with extensive experience in the life science industry. We can provide specialized services or collaborate as your quality partner, as well as providing a QA HelpDesk service.
- Quality management systems (QMS), construction, implementation, and maintenance * Assessment and release by a qualified person (QP), evaluation of serious deviations, change management, and corrective and preventive action (CAPA)
- Product quality reviews (PQRs)
- CAPA processes and deviation management, design, and execution
- Change management, design, and execution
- Quality assurance for different purposes, such as project QA, QA computerized systems, and QA in product-development projects. We have QA specialists in areas such as pharmaceuticals, medical devices, and cosmetics.
- Complaints handling, claims and refunds, including design and execution
- Quality assurance in projects, programs, software
- Gap and risk analyses
- US Food and Drug Administration’s Title 21 CFR Parts 820 and 11, ISO 13485, ISO 9001
- Good manufacturing practices (GMP), good distribution practice (GDP), good laboratory practice (GLP), good pharmacovigilance practices (GVP)
- Regulation (EC) N° 1223/2009 on cosmetic products
You benefit by ensuring you have access to a quality partner with a long-term view of your organization and its needs, without having to invest in the continuous support of a consultant.
- QA Operations Support
- Project-related services (IT, processes, production, and lab)
- Regulatory updates via subscription service
- Support as needed
- Issuing standard operating procedures (SOPs)
- Issuing and updating a pharmacovigilance site master file (PSMF)
- Daily management of side effects
- Providing a qualified person (QP) responsible for pharmacovigilance (QPPV) and a deputy QPPV on 24-hour, 7-days-a-week availability
- Literature monitoring
- Market intelligence/surveillance activities
- Periodic safety update reports (PSUR ) and postmarket surveillance (PMS)
- Risk management planning (RMP)
- Training in pharmacovigilance
- Subscription service, including a subscription for updates of specific regulations and assistance in interpreting how changes in regulations affect your operations
- Internal reviews, including internal review of the pharmacovigilance system, and support and advice before, during, and after external inspection by a governmental authority or customer
- Gap analyses
- Quality assessment
- Risk analyses
They fulfil the very high demands we place on our consultants, both in terms of competency and personal qualities.
Above all, I am very pleased with their ability to listen to our needs and then work independently to develop suitable solutions.
Learn more about our Quality & Compliance offering
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