Article featured in European Pharmaceutical Manufacturer: The UK’s separation from the EU could have implications for regulatory harmonisation, and increase administrative workloads at a time when responsible teams are already overstretched and experienced talent is hard to find. Dr Jutta Hohenhörst of Schlafender Hase asks what impact this could have on IDMP preparations.
Article featured in the Journal for Clinical Studies: Life sciences technology vendors and consultancies are busy promoting Identification of Medicinal Products (IDMP) compliance solutions, which seems odd given that many details of the final requirements have yet to be published.
Article featured on Pharmiweb.com: How will Brexit and other challenges to the status quo affect plans to raise life sciences standards across Europe and internationally, asks Schlafender Hase’s Dr. Jutta Hohenhörst.
Article featured on PharmExec.com: If pharma companies want to hold their own in the current climate, they must embrace rather than resist market change. Schlafender Hase’s Peter Muller provides his analysis of five trends that threaten the status quo.
Article featured in the Journal for Clinical Studies: Bringing a new drug to market costs millions, so it’s highly risky to leave product labelling and packaging to chance. Especially if it’s expensive professionals giving hours of their time to these repetitive manual processes
Article featured in International Pharmaceutical Industry: Growing complexity in life sciences is raising the risk of product mislabelling, potentially putting lives in danger and leaving companies open to hefty fines and delays in product availability, warns Marc Chaillou of Schlafender Hase.
If you or someone you know is still doing manual proofreading, this is the perfect whitepaper! Regulations are increasing, and all regulatory hands need to be on deck. Companies can't afford to have highly qualified professionals manually proofreading material.
Article featured in International Pharmaceutical Industry: Regulators’ appetite for transparency and standards adherence is increasing. Their aims are to prevent manufacturers from misleading consumers, and to remove any risk of people overdosing on active ingredients
Article featured in Pharmaceutical Manufacturing and Packaging Sourcer: The line between pharma and food is blurring with the surge in nutraceuticals, and regulators are now playing catch-up. For organisations lacking a life sciences heritage, the stringent rules will affect all sorts of internal documentation processes.
Article featured in Pharma Exec: Pharma and food are becoming closer and closer, presenting a great opportunity for life sciences firms to diversify — as long as they realise that other manufacturers they acquire or partner with are unlikely to have the same regulatory controls in place.
Article featured on Pharmaiweb: The drive towards preventative healthcare is placing new focus on food – from the dietary qualities of packaged produce, to the health claims of so-called ‘nutraceuticals’. It has captured the imagination of governments, healthcare providers, the general public, and the life sciences industry.
Article featured in Inside Food: In May the FDA announced new guidance on food labelling, mirroring a move in Europe to improve transparency and safety for consumers. The aim is to provide more detailed health and nutrition information and make this more prominent, but the new requirements will add to the workload for manufacturers and their partners.
Article featured on Pharmiweb: It’s hard enough for pharma organisations to find and keep top regulatory talent in the current climate, so the last thing they can afford is to lose valued skills to a competitor. To reduce their exposure, firms need to automate more of their routine processes.
Article featured in International Pharmaceutical Industry: The life sciences industry is drowning beneath a sea of new regulations and directives. As well as being immensely demanding from a risk management perspective, the associated administration is detracting from core activities.
Article featured in Pharma Exec: Soaring regulatory requirements are tying up RA and QA talent: skilled and experienced people who must now devote hours to mind-numbing administrative tasks to ensure updated product information is accurate and compliant. This is an inefficient use of costly resources, and it undermines job satisfaction by failing to channel professionals’ intelligence.