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
Engineering is essential for translating strategic objectives into compliant, efficient, and operational facilities and processes. Within a regulated life sciences environment, engineering activities span the complete project life cycle, from early feasibility and conceptual design through to operational readiness. Engineering projects cover production facilities, pilot plants, and laboratory environments within the bio pharmaceutical and healthcare industry. This includes layout and construction, cleanrooms and supporting areas, utilities, production processes, laboratories, and associated equipment. A structured engineering approach ensures alignment between technical design, regulatory requirements, and operational needs, enabling a controlled and efficient transfer to Operations.
Here you fill find all our Engineering solutions.
CQV
Commissioning, Qualification, and Validation are critical to ensure that facilities, utilities, systems, and equipment perform as intended and are ready for GMP operations. Effective CQV safeguards patient safety, product quality, and regulatory compliance while supporting reliable and efficient manufacturing. CQV activities span all project phases, from design and construction through to a fully qualified and validated state. This includes risk based qualification strategies, commissioning support, qualification of utilities and equipment, process validation, cleaning validation, and computer system validation. A well executed CQV approach ensures alignment with current regulatory expectations and industry best practices, enabling a smooth transition into routine GMP operations.
Here you will find all our 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 about our ATMP expertise. Here you can read more about our Dutch ATMP Summit.
