Biotechnology & Pharmaceutical
Background and challenges
In the fast-growing and highly innovative biotech industry, the development phase of innovative drugs and therapies is a complex challenge.
Today, many biotech companies do not always have the critical resources for validation, quality assurance, regulatory affairs, clinical development, and quality management.
We support these biotech companies in this crucial challenge. As a specialist with solid experience in life sciences consulting, we provide the best consultants with a vision to optimize our partner’s processes.
Why choose pI Life Sciences
Belgium is one of the leading biotech centers in the world.
Against this backdrop, pi Life Sciences have become a preferred consultancy service partner for the biotechnology and pharmaceutical industry.
From our offices in Belgium and the Netherlands, with more than 170 employees, pi Life Sciences support companies in developing, transferring, producing and distributing new biotechnology and pharmaceutical products.
Background and challenges
The development of medical devices is regulated by laws that govern their safety and effectiveness throughout their life cycle, from design to use and distribution. A risk-based classification system determines the pre- and post-marketing requirements for medical devices.
Through quality management and various processes in the post-marketing phase, product quality is assured, to ensure the continued safety and effectiveness of the medical device throughout its life
Why choose pI Life Sciences
At pi Life Sciences, we have the expertise to help medical device manufacturers and distributors meet the market’s regulatory requirements throughout a medical device’s entire life cycle.
Our regulatory and quality experts will support you throughout your project to bring a medical device to market safely and effectively. Our consultants will implement the FDA Quality Systems Regulation or the new EU Medical Device Regulation (MDR) and its equivalent for in vitro diagnostics, the In Vitro Diagnostic Regulation (IVDR), to the earliest stage in your project, enabling a managed risk-based approach.
MEDICAL DEVICES
ATMP
Advanced Therapy Medicinal Products
Background and challenges
ATMP is the short name for Advanced Therapy Medicinal Product and translates into « advanced therapy medicine ». It is therefore a category of medicines that includes gene therapies, cell therapies and tissue therapies.
ATMP treatments are very sophisticated and require complex biotechnological manufacturing processes to support the patient’s needs. This represents a massive challenge in the life sciences sector related to production, quality control and regulatory affairs.
The regulatory requirements combined with the long development time of these innovative therapies result in high production costs and thus impact the cost of the final product. How can we improve the development steps to support an effective treatment that changes patients’ lives drastically?
Why choose pI Life Sciences
We employ highly qualified consultants in all the ATMP production life cycle dimensions. Our experts in process development, manufacturing, quality control, regulatory affairs, and quality management can work with you to build or upgrade your manufacturing and product control strategy.
