Farma Consulting & Partners is a trusted partner for quality assurance (QA), Qualified Person (QP), and validation activities within the life sciences industry. We are committed to building sustainable, long-term relationships and strive to bring your products to market safely and to efficiently implement, optimize, and validate your quality systems.
With a dedicated team of experienced consultants, we constantly challenge the status quo and support our clients in the highly regulated pharmaceutical sector. Our services include quality management, QP services, audits, qualification and validation, automated system validation, and QMS design for medical devices in accordance with ISO 13485:2016.
The word “Partners” is central to our vision, in which we view partnership from various perspectives. We place great importance on the central role our clients play within our vision. As a consulting firm, we always strive to deliver the highest quality, because we believe this contributes to sustainable relationships and partnerships with our clients.
To deliver this high level of quality, our own consultants play a crucial role in our story. We strive to create a challenging and pleasant work environment where like-minded high-potential individuals inspire one another and can grow on a personal level.
Explore our services and discover how we can support you. With a wide range of solutions, we help you address a variety of challenges, tailored to your organization.
News
Just as every project has its pitfalls, the same is true for a Manufacturing Execution System (MES) implementation project. Implementing electronic batch records is no easy task. That’s why, in the blog below, we’ll share a few pitfalls so you can prepare for a successful implementation within your company.
By the end of this month (31st of January 2025), the final deadline is reached in the transition period for the implementation of the European Clinical Trial Regulation (EU-CTR). What is it and what is the difference with the previous European Clinical Trial Directive (EU-CTD)?
In the complex and highly regulated world of the pharmaceutical industry, project management plays a pivotal role to bring life-saving medications and treatments to the market. From drug discovery to clinical trials and regulatory approval, effective project management is essential for managing timelines, resources, and compliance. Let’s dive in some practical tips and tricks specifically for navigating the complexities of project management in the pharmaceutical sector.
Radiopharmaceutical and selective internal radiation treatments have emerged as a transformative force in the pharmaceutical industry, offering precision, personalized therapies for patients with conditions such as cancer and other serious diseases.
Since the implementation of the Medical Device Regulation (MDR) in Europe, companies have had to maintain and execute a post-marketing surveillance (PMS) procedure. This systematic process involves collecting and analysing data on the performance and safety of medical devices after they have been released to the market. The primary goal is to help manufacturers identify and address potential issues that may arise during actual use, monitor the market for known risks, and identify new risks.
In the pharmaceutical industry, product quality is of vital importance. This is particularly true for medicinal products that are sensitive to temperature fluctuations, such as vaccines, biologics, and certain medications that must be stored and transported in a controlled environment. Within this process, the CQV (Commissioning, Qualification, and Validation) expert plays a crucial role, especially within the cold chain division, which is responsible for monitoring product quality during the transport and storage of these temperature-sensitive products. This blog outlines the various aspects a CQV expert must consider in this context.
In the life sciences industry, maintaining high quality standards is critical not only to the success and sustainability of organizations but also to patient safety and compliance. ISO 9001:2015, part of the ISO 9000 family, provides a robust framework for quality management systems (QMS) that can be used in organizations in the life sciences, including pharmaceutical, natural technology, including medical devices. This article examines the key features of ISO 9001:2015, its benefits, implementation methods, potential pitfalls, and impact in the life sciences.
Normec is a leading organisation in the TICC industry (Testing, Inspection, Certification, Compliance). Our areas of expertise range from (drinking) water quality, air quality and soil quality to fire safety, food safety, management systems, fair labour, good working conditions and social compliance. Every day, we work towards a safe, healthy and reliable working and living environment. For this and future generations.
