Life Science: Quality & Regulatory
Achieving Excellence in Life Science Quality with Precision and Expertise
Today’s standard and regulatory framework is complex. We support Life Science companies in developing, introducing, and producing compliant products while considering the latest standards and regulations. This reduces the burden of reinventing the wheel by centralizing knowledge and making use of our international experience and network of consultants.
Life Science: Quality and Regulatory
Center of Excellence at Amaris Consulting
Our Center of Excellence will guide you through the entire lifecycle of validation activities from the design phase to decommissioning. Our team can also help addressing potential deviations and delivering all the necessary documentation to ensure compliance with the highest standards, such as cGMP, FDA, ISOC.
Equipment / Facilities / Utilities Qualification
Computerized System Validation
Our offers can be combined to provide the best tailor-made solution.
We provide the knowledge and resources to setup or extend your Quality Management System (QMS) based your specific needs, considering the products you manufacture and your target market. We offer resources for enhancing existing processes, supporting development projects using the QMS and ensuring that products are produced in accordance with the specifications.
In the complex world of standards and regulations, we leverage our extensive experience to provide support and guidance on the most effective and efficient approach to ensure compliant products are successfully introduced to the desired markets. We can assess various aspects of product development, including design documentation, technical files, intended use, device classification, and more.
Every organization faces a phase during product development where external advice or audits are necessary to prepare for the next step in maturing the Quality Management System, organizing external audits or inspections, or improving technical product documentation. With our assessment and auditing toolkit, we can advise on various subjects in the Healthcare domain, delivering rapid results in a short time frame.
Our teams’ knowledge and experience, combined with our context-driven approach, allow us to customize trainings programs to meet your needs in areas such as standards, procedures, and regulations. We can deliver these trainings using a classical approach or through an academy, a boot camp, or a quality learning model.
When implementing new processes, equipment, or systems, it is essential to establish periodical validations phases to guarantee their safety, effectiveness, reproducibility, and quality. Regulatory texts govern the different validation phases and their associated documentation, including:
- Commissioning, Factory Acceptance Testing (FAT), and Site Acceptance Testing (SAT)
- Risk Assessment
- Validation Strategy (e.g., Project or Site Validation Master Plan, Validation Plan)
- Design Review and Design Qualification
- Installation Qualification
- Operational Qualification
- Performance Qualification
- Process Performance Qualification
- Process Validation
These validation principles are applied to all types of processes, equipment, and systems including:
- Manufacturing, Cleaning and Sterilization processes
- Production equipment and lines: formulation, filling, primary and secondary packaging, sterilization, and for all different galenic forms and medical devices
- Quality control equipment and analytical method transfers
- Facilities and utilities equipment: such as FMS/BMS, HVAC, cold rooms, climatic chambers, and water loops
- GxP or non GxP Software
Using risk-based approach and periodic reviews, our expert team will provide all the necessary validation documentation from Standard Operating Procedures (SOPs) to Project or Site Validation Master Plan (VMPs) and will deliver the protocols and reports to maintain the validated state of the process, equipment, or system. We will adapt to your tools and software (Quality Management System: change control, anomaly management and documentation management).
The following is a non-exhaustive list of the sector solutions we provide. If you want to assess the relevance of these solutions to your own industry, please do reach out to us.
Large Pharmaceutical companies
We are specialized in ensuring compliance with industry standards and regulations, particularly in introduction of new drugs and (similar) biologicals. Our services encompass quality assurance, regulatory affairs, and support during the transfer of DHF and review of technical files.
Medical devices companies
We focus on ensuring compliance with the standards and regulations in EU and the US, among other countries not excluded. Our expertise covers new product introduction, expansion into new markets, quality assurance, and regulatory affairs. We also support during the transfer of DHF and review of technical files.
We provide valuable support to companies operating at the intersection of biological, engineering and computer sciences. Across diverse fields such as pharmaceutical research, food production, fuel manufacturing, chemical production, biodiversity preservation and handling of hazardous materials, our experienced team offers guidance and throughout the development and production phases.
We help our customers to set the right prices for their products & clients. We help them to forecast their demand (per location) and identify the best locations for shops. For e-shops, we assist with product recommendation engines and next best action marketing.
Why Choose Amaris Consulting?
Ensuring compliance and product quality requires the alignment of business teams and technologies. Our teams are trained to proactively avoid potential blocking points, to help you release new products and to keep up with evolving regulations and standards.
Our Life Science: Quality and Regulatory Center of Excellence team:
benefits of our Life Science Academy program, which enables us all to keep up to speed and avoid delays and knowledge gaps.
has expertise in every area of the Life Science industry, including pharmaceutical and biotech. This assures you to have the right people with the right skill set available.
has experience in various scales, ranging from small maintenance start-ups for to large, complex developments and projects for local, national, and international client.