Quality & Regulatory
Engineering Innovation in Life Sciences
Ensuring product quality and regulatory compliance is fundamental in Life Sciences, where every process must meet strict global standards. ALTEN supports organisations across Quality & Regulatory activities, from Quality Assurance and validation to regulatory affairs and compliance management, with an approach tailored to each client’s environment. Our teams help build robust quality systems, streamline regulatory processes, and ensure alignment with international health authority expectations. By combining operational expertise with in-depth regulatory knowledge, we enable organisations to maintain compliance while sustaining performance and accelerating product delivery. This is where structured quality transforms complexity into confidence.
What is QA?
Quality Assurance (QA) in the pharmaceutical industry is a systematic, proactive approach to ensuring that products, whether drugs, biologics, or medical devices, consistently meet predefined quality standards, regulatory requirements, and safety expectations. QA encompasses the entire lifecycle of a product, from development and manufacturing to distribution and post-market surveillance. Its core objective is to prevent defects rather than merely detect them, by embedding quality into every process through robust documentation, risk management, and compliance with global regulations like Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP).
ALTEN works alongside your quality teams to secure timely resolution, regulatory alignment, and operational continuity. Since 2019, our deviation management service has resolved over 5,000 deviations and closed more than 1,000 complaints in Belgium alone, with successful deployments extended to other countries, like Switzerland and Canada.
Case study
In the complex manufacturing of vaccines, identifying the root cause of any deviation is essential to patient safety and production continuity. ALTEN supports our client, managing their end-to-end NC/CAPA process. Our consultants provide the technical rigor required to investigate, solve, and prevent recurrences in high-compliance environments. The client required a flexible, high-caliber team to integrate into their Manufacturing Units. Click to learn how!
What is QC?
Quality Control (QC) is the reactive, testing-focused branch of quality management in the pharmaceutical industry, designed to verify that products meet predefined specifications before release. Unlike Quality Assurance (QA), which focuses on process design and prevention, QC involves direct testing, sampling, and inspection of raw materials, intermediate products, and finished goods. Its primary goal is to detect deviations, such as impurities, potency issues, or contamination, using scientific methods like chromatography (HPLC), microbiological assays, or physical inspections. QC ensures that every batch complies with strict regulatory standards (e.g., USP, EP, or ICH guidelines) and is safe for patient use.
ALTEN contributes directly to your QC activities through sterility testing, bioburden analysis, environmental monitoring, and analytical method validation under GMP conditions. By reinforcing data integrity, method performance, and regulatory alignment, your laboratories gain execution speed without compromising compliance.
Case study
In vaccine manufacturing, the integrity of the production environment is the single most critical factor in ensuring patient safety. By integrating expert microbiologists into the site operations, we ensured that every process, from sterility testing to facility qualification, strictly adhered to the highest GMP standards. To prevent contamination and ensure the safety of innovative biopharmaceutical products, the production environment requires constant and stringent control.
What are Regulatory Affairs?
Regulatory Affairs (RA) is the strategic bridge between pharmaceutical companies and global health authorities, ensuring that products, whether drugs, biologics, or medical devices, comply with all applicable laws, regulations, and guidelines. RA professionals interpret and implement complex regulatory requirements (e.g., FDA, EMA, ICH, or national agencies) to secure and maintain market approvals. Their role spans the entire product lifecycle, from preclinical development to post-market surveillance, with a focus on safety, efficacy, and legal compliance. RA is critical for navigating the evolving regulatory landscape, minimising risks of non-compliance, and accelerating time-to-market for innovative therapies.
ALTEN works alongside your teams on regulatory submissions, labelling activities, and lifecycle management from early development through post-approval changes. We ensure alignment with EMA, FDA, and local health authority expectations, helping you secure approval timelines and reduce compliance risks across the product lifecycle.
Case study
Our client, a global leader in consumer health, requires seamless regulatory oversight to manage its diverse portfolio of medicines and supplements across international markets. ALTEN provides specialised support to their CMC (Chemistry, Manufacturing, and Controls) team, ensuring that complex product variations, annual reports, and regulatory submissions are prepared with precision and compliance to facilitate rapid product availability. Operating in a highly competitive consumer health market requires agility in managing product life cycles while strictly adhering to international health authority requirements. Read more about the challenges!
What are Quality Systems?
Building on the role of Quality Assurance (QA), a Quality System represents the comprehensive, structured framework that formalises and integrates all QA activities, alongside other critical functions, into a unified, organisation-wide approach to quality management. While QA focuses on preventing defects and ensuring process reliability, the Quality System provides the infrastructure, processes, and tools needed to sustain, measure, and improve quality across every stage of the product lifecycle.
ALTEN supports your teams in designing and optimising Quality Management Systems (QMS) that combine regulatory compliance with operational efficiency, we help structure and digitalise your quality processes. We enable traceable, automated workflows while fostering a culture of continuous improvement aligned with FDA, EMA, ICH, and ISO standards.
Case study
Our client, a global leader in vaccines, is advancing its digital transformation by upgrading its Quality Control laboratory to ensure full data integrity compliance. ALTEN provides dedicated support to structure user requirements, manage change control activities, and ensure the compliant implementation of new devices. By working closely with laboratory and quality teams, ALTEN contributes to strengthening compliance, improving data reliability, and supporting the transition toward a digitally enabled laboratory environment.
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