Quality Management and Quality Strategy services for pharmaceutical companies
Helix Life Sciences is a specialized consulting firm, based in Geneva, Switzerland, providing integrated solutions and tailored services to innovative pharmaceutical companies in Swiss and European markets.
Our mission is to help companies accelerate product launch and effectively maintain their products on the market, providing Quality Assurance strategy, Quality Management System (QMS) development and maintenance, as well as obtaining and maintaining appropriate product licenses.
Compliance with GMP & GDP requirements
We bring you the best of industry expertise towards obtaining and maintaining your Manufacturing/Importer Authorization (MIA), Marketing Authorization (MA) or Wholesale Distribution Authorization (WDA). Our team can act as both Qualified Person (QP) and Responsible Person (RP) on these licenses, hosting regulatory agency inspections as required.
Qualified Person (QP) Services
Our QP Services are designed to help you from product development to manufacturing and batch release, ensuring that your products comply with all regulatory (GMP/GDP) requirements and regulations.
Elevate your organizational performance with our expertise in defining an impactful quality strategy. Our approach involves a risk-based methodology that incorporates holistic knowledge management, fostering continuous improvement.
Quality Management System Development
We can help you develop a Quality Management System (QMS) tailored to your organization’s needs, including policies, procedures, and documentation to ensure compliance with GMP/GDP guidelines.
Responsible Person (RP) Services
We provide full Responsible Person (RP) and Qualified Person (QP) representation in conformity within the Swiss regulatory framework (Swissmedic).
We help you navigate the intricate regulatory landscape with confidence. We serve as your compass, guiding you through regulations and standards, and conducting reviews of your processes for alignment with GMP/GDP guidelines.
Liaising with Regulatory Authorities
Entrust us to be your liaison to regulatory authorities, ensuring seamless provision of all requisite documentation and information thus facilitating prompt and efficient communication.
Empowering RP through Training and Qualification
Empower your Responsible Person (RP) through our training and qualification programs. Equipping them with requisite skills and knowledge ensures effective execution of their responsibilities.
Regulatory Auditing and Inspection
We will support you in preparing for regulatory audits and inspections and provide assistance during the inspection process.
Our Qualified Persons (QPs) conduct thorough reviews of your product documentation to ensure that it meets all regulatory requirements and complies with GMP standards. We offer actionable insights for any necessary changes or improvements.
Batch Release Assessments
We perform rigorous assessments of your product batches to ensure that they meet all regulatory requirements and can safely be released to the market.
LET’S GET IN TOUCH
Need help or want to enquire about our services ?