PHARMACEUTICAL & BIOTECHNOLOGY
In this market sector, safety and efficacy of medicines remain a top priority for drug companies and regulatory bodies.
At SPGL, this is at the forefront of our thinking as evident in our methodology. Our knowledge of the regulations, combined with our ability to integrate engineering, construction, commissioning and validation, enhances quality and reduces our clients’ ‘Time to Market’.
We are dedicated to delivering good value quality medication, by adopting a risk-based approach to commissioning & qualification/validation. We anticipate, analyse and manage every aspect of risk throughout the project lifecycle.
MEDICAL DEVICES & DIAGNOSTICS
The Medical Device & Diagnostics sector is gaining great importance in ensuring a better quality of life across the globe. New medical technologies are transforming the healthcare landscape with solutions to address chronic diseases conditions and revolutionize the way treatments are administered.
As recently evident, diagnosis is also fundamental for successful outbreak containment, from Ebola to the current Covid-19 pandemic. It is clear that the ability to diagnose accurately and abundantly is critical.
Whatever the instrument, be it an apparatus, machine, appliance, implant, reagent or calibrator, we at SPGL fully understand the different classifications and the application of these regulated devices. Our teams are fully experienced and have worked on numerous facilities involving some or all of these instruments and devices.
We can bring value by applying the appropriate standards as well as fast-track these systems to meet the rapid and ever-changing needs of society.
REGULATED CONSUMER PRODUCTS
Whether you are producing a medicated toothpaste, a make-up kit or simply a lip stick, we are aware of the impact of quality on the application of such regulated products.
At SPGL, we implement quality through a risk-based approach to commissioning and start-up, focusing best practice verification and documentation procedures on the areas most likely to affect product quality, cost and schedule.
Expert in commissioning facilities for the pharmaceutical industry, SPGL can produce highly detailed documentation for close scrutiny by regulatory authorities. Depending on the type of product, we simply adjust the level of detail to suit each project.
