Faced with new regulations, the pharmaceutical and medical device industries have an obligation to comply.
For example, the implementation of the EU Falsified Medicines Directive, initiated 4 years ago, will make it possible, from February 2019, in most of the 28 EU Member States, to track and identify each box of medicinal product using a unique serial number. This number, represented by a QR code printed on the packaging of the product, is registered in a European Union database and is checked by the Pharmacist before the drug is given to the patient, thus eliminating any risk of counterfeiting.
- Qualify and validate the production and distribution systems impacted
- Master the regulatory issues related to the emergence of combined products
- Anticipate potential future requirements such as aggregation
All medical devices are potentially connectible. Some are already connected and working through applications that provide health professionals and patients with decision aids, diagnostic possibilities or automatic treatment management. There are many areas of application, including telemedicine, addiction management and chronic disease management.
Experiencing a growth rate above 10% per year, the e-health market is estimated to be worth $400 billion by 2022.
- Develop these embedded software in compliance with the regulatory standards of the target market
- Prove the regulatory compliance of these products, which is complex due to the requirements related to the status of DM (Medical Device) and the presence of a software
- Ensure personal data security and stakeholder trust
A combination product is a health product in which a drug and a medical device are combined. Similarly to an embedded software, innovation and technological progress are making this type of alliance possible more and more and here again the fields of application are numerous. One association that has become commonplace is the combination of hip replacement and antibiotics, which aims to inhibit bacterial adhesion.
For the manufacturers, the issue is complex because these “borderline” products have only one status, Drug or DM, and that each status has its own specific regulatory regime. Here, the regulatory strategy is the most important, from the design phases.
- Master both the normative constraints of DMs and those of drugs, to develop a registrable combined product
- Validate the manufacturing process for these combination products
- Be able to qualify and classify the combined product to determine the applicable regulatory status, and file for registration
The pharmaceutical industries must produce more at competitive cost in order to meet the budgetary efforts required by health systems, increased competition from generic drugs and growing demand from emerging countries.
In 2017, the global drug market exceeded the threshold of 1,000 billion dollars of revenue, increasing by 6% compared to 2016, with a market share in the United States of 49%.
- Share R&D investments
- Renew production tools (e.g.: automation)
- Requalify these upgraded production sites
OUR SUCCESS STORIES
In order to be able to launch large-scale clinical trials (phase 3) of a new vaccine, one of the ten international pharmaceutical industry giants has invested in the construction of a new production site in Belgium. ALTEN has been entrusted with the responsibility of qualifying equipment performance (PQ) and drafting the operating instructions.Learn more
Certain cosmetic products are considered as OTC (Over The Counter Drugs) in the United States. A prestigious luxury French brand contacted CADUCEUM (specialist subsidiary of the ALTEN group) to bring its facilities into compliance with FDA (Food and Drug Administration) requirements, which is an essential prerequisite for the marketing of its key products.Learn more
In the context of developing an immunosuppressive drug for post-renal transplant patient, a global leader in generic and biosimilar medicines outsourced the study of the benefits of the pharmacokinetics profile of its product to AIXIAL (specialized subsidiary of ALTEN Group).
ALTEN has recognized expertise in medical devices and has set up two service centres (Software and Hardware) to support the activities of the R&D centre of one of the world’s leaders in medical imaging. The work carried out by our engineers is in the fields of mammography, interventional radiology and the development of advanced medical imaging applications.Learn more
The growing use of digital technologies in pharmaceutical industries, in particular, makes CSV (Computer System Validation), which controls the automated production of drugs, necessary. This validation provides the documented proof that a software application or a computer system will operate continuously and will therefore meet predefined GxP (Good Practice) guidelines.Learn more
Sanofi, GSK, Roche, Baxter, Servier, Pierre Fabre…
Medical device industry
GE Healthcare, Fresenius, Siemens Healthineers, Philips Healthcare, Air Liquide, Biomerieux, Carmat, Guerbet, BD…