COVID-19: We are here to help
We are here to help, that is our commitment.
During the Corona pandemic, business might not be as usual. Some challenges require the best of all managers and employees. Some may wonder how they can continue their activities such as clinical trials, while others are urgently trying to manage their workload. Regardless of the situation, we are open for you to express your concerns. We will do everything we can to help.
How we can help
Engineering production facilities
Over the last few weeks, demand for your products might have skyrocketed and left you wondering if you could improve or expand your facility in a quick manner. Progress-PME is your partner for engineering projects. We can manage your building from basic design to construction and qualification. We have an excellent track record with fast-track construction and qualification projects.
Now, more than ever, you might need support in translating complex laws and regulations into clear standard operating procedures of your quality system. We can help your organisation to become and remain in control.
Scale-up lab- or production
During the Corona Pandemic, companies are considering how their products or facilities might be of use. Sometimes they require scale-up and./or technology transfer to other sites to meet increased demand. We have a broad knowledge with upscaling and technology transfer. For example: upscaling of batch size limiting steps of production processes, technology transfer to 2nd site to increase production output, optimising analytical lab processes using LEAN.
Devolopment, testing and registration
Are you considering a new product? Progress-PME employees are very experienced in the CMC trajectory from product development to product registration. We know all applicable laws, regulations and guidelines (EMA, FDA, ICH) and can assure that the final production process is developed in accordance with Quality by Design (QbD) principles. Also, the production process, including applicable equipment and analytical testing methods are properly validated, and all documentation is generated to allow successful product registration at the competent authorities.