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Progress – Experts in Life Sciences offers a variety of Expertise arising from an extensive portfolio of multidisciplinary assignments in the (bio-)pharmaceutical industry. Over more than 25 years, we have developed knowledge of technical aspects, legal requirements, quality management systems, modern technologies such as ATMPs and methods to make processes efficient (Lean) and projects successful (PRINCE2). In consultation with our clients, we ensure that projects are tailor-made and that products are developed and delivered in accordance with applicable and current (GMP) standards and regulations.
CMC and MSAT
Chemistry Manufacturing and Controls (CMC) involves developing, testing, documenting, and registering a new pharmaceutical product, the production process, and the associated analytical methods. Manufacturing Sciences and Technology (MSAT) and/or Analytical Science and Technology (ASAT) departments have a strong supporting role towards the commercial manufacturing departments and the QC department, respectively. Many (bio-)pharmaceutical manufacturing organizations have implemented such departments in their GMP Operations organizational charts.
Here you will find all our CMC and MSAT solutions.
Quality
Patient safety, product quality and efficacy, and compliance are key in a life sciences environment. In addition, (bio-)pharmaceutical organizations strive for optimal business efficiency and product release time. Quality plays an essential role in achieving these objectives. Auditors such as IGJ and US FDA assess whether organizations adhere to their agreements and regulations. Our specialists and project managers can support you in implementing or improving your quality systems and processes and can guide you before, during and after inspections.
Here you will find all our Quality solutions.
Engineering and CQV
Progress is your partner for engineering projects related to production, pilot plants and laboratory facilities in the (bio-)pharmaceutical and healthcare industry. We can manage, organize, and/or implement your project from feasibility through to transfer to the operation of a qualified and validated facility and/or process.
Here you will find all our Engineering and CQV solutions.
ATMP
Advanced Therapeutic Medicinal Products (ATMPs) represent novel treatment modalities, including cell & gene therapy as well as (genetically modified) tissue transplantations. These therapies are developed through collaborative efforts between biotechnology companies and hospitals. The treatment involves administering (genetically) engineered cells that initiate a specific process in the patient’s body. Given the high costs, severely ill patient demographics, and the limited availability of both products and time, ATMP treatments present unique challenges.
At Progress, we bring in-depth knowledge and extensive experience to support organizations in developing and producing ATMPs. We know all the essentials and specifics for ATMP cleanroom design and have extensive knowledge of the regulatory requirements for ATMP GMP production. We use field-proven strategies to shorten time-to-market and reduce the cost of goods throughout the entire process development trajectory, from raw material evaluation to final product release to market authorization. Additionally, we organize the annual Dutch ATMP Summit (DAS) featuring leading speakers from the field.
Here you can read more out our ATMP expertise. Here you can read more about our the Dutch ATMP Summit.
