Latest news with #RegulatoryAffairs
Forbes
30-06-2025
- Business
- Forbes
How AI In Medical Writing Will Save Money And Accelerate Drug Delivery
The tightly regulated life sciences sector needs specialisy AI solutions for content produciton Generative artificial intelligence (GenAI) promises to transform the life sciences sector. But while excitement is understandably mounting about the potential to use the technology to develop new drugs and save lives, other uses of AI in the sector are often overlooked. That's despite the huge value on offer here. A recent study from the consultant McKinsey found that leaving aside clinical and R&D use cases for GenAI in the life sciences sector, the technology has the potential to produce more than $50 billion of value each year across the pharmaceutical industry value chain. Medical writing is one significant part of that opportunity. The highly-regulated process of creating literature for regulators, healthcare professionals, patients and other key stakeholders is hugely costly for life sciences business. Research from Deloitte suggests that automating more of this process could reduce the workload of a medical writer by up to 30%, driving cost savings of up to $30 million a year for a large life sciences company. A survey published last year by the Regulatory Affairs Professionals Society found 57% of companies planned to invest in technology to support their medical writing workflows. There's also the potential to speed up the process of bringing new treatments to market, since getting regulatory approval for new drugs often depends on multiple submissions and reports. 'One immediate area of opportunity for streamlining clinical trials is clinical and regulatory medical writing,' concluded the American Medical Writers Association in a recent paper. 'GenAI has the potential to revolutionize medical writing by automating routine tasks, improving consistency and quality, and enabling faster turnaround times.' Established life sciences industry players such as Parexel, Syneos Health and Trilogy are increasingly developing solutions that meet this need, but the sector is also home to a number of innovative new entrants. LogicFlo AI is one such start-u. The Boston-based company is today announcing it has raised $2.7 million of seed funding from investors in order to scale its agentic AI business. The contention of co-founders Udith Vaidyanathan and Arun Ramakrishnan is that while AI can help life sciences businesses produce vital content and documentation more efficiently and cost-effectively, the highly specialised and regulated nature of the industry means it needs solutions that have been designed expressly for this purpose. 'The cost of an inaccuracy or omission in life sciences is potentially huge,' argues Vaidyanathan. 'Generic AI tools aren't reliable enough for these tasks and processes, and it's also critical that every claim made in documentation is sourced so that it can be checked and verified.' LogicFlo's approach has therefore been to develop a set of AI agents that can interact with life science companies' existing technologies – systems such as Veeva and IQVIA – in order to automate the creation of the content they need. Every piece of literature produced can then be checked by a human being, but staff no longer need to spend countless hours developing the documents from scratch in the first place. 'The life sciences industry is employing thousands of highly-qualified professionals who then have to spend huge amounts of their time on medical writing,' says Vaidyanathan, who saw this problem first-hand in his previous role supporting the CEO office at the global life sciences business Abbott. 'If we can reduce that burden, we can free them up to do much more of the work they're qualified for.' LogicFlo founders Udith Vaidyanathan and Arun Ramakrishna It's a proposition that has already seen LogicFlo, founded last year, win a number of commercial customers, including a Fortune 500 life sciences business with around 10,000 professionals in functions such as medical affairs, quality, regulation and promotional content. 'Traditional automation has failed life sciences because it's too rigid, too brittle and too out of touch with how people actually work,' adds Ramakrishnan In practice, LogicFlo's technology can be used for a range of tasks where the stakes are particularly high, including medical literature writing, medical communications and information response, regulatory submissions and responses, and the production of a range of promotional and marketing materials. In each case, life sciences businesses are held to much higher standards than their counterparts in non-regulated industries and therefore need specialist tools to produce accurate and detailed material that stands up to close scrutiny. It's this differentiation that has attracted investors to LogicFlo, which plans to use its funding for recruitment and engineering. The round was led by Lightspeed with participation from a number of business angels from across the healthcare and life sciences sector. 'LogicFlo's AI agent platform empowers medical affairs and commercial teams to build agentic workflows across diverse use cases, dramatically boosting productivity,' says Rohil Bagga, VP of investments at Lightspeed. There's certainly plenty of market to go at. The market for AI In medical writing was worth $685 million last year, according to Credence Research, but will grow to $1.58 billion by 2032, it estimates. That's growth of around 11% a year – likely enticing enough to attract more new entrants to the sector in the coming months and years.
Khaleej Times
11-06-2025
- Business
- Khaleej Times
UAE authority finds multiple gas use violations, launches awareness campaign
Poor installation, substandard equipment, and lack of regular maintenance are among the most common risks associated with gas use in Abu Dhabi, according to field surveys and inspections conducted by the Abu Dhabi Department of Energy (DoE). The department observed frequent violations among residents using LPG systems, including domestic workers and labourers who use gas appliances, as well as employers in restaurants and cafeterias who are responsible for ensuring their workers are adequately trained. Violators also included recruitment companies involved in hiring workers for such roles. Among the most common violations were the use of substandard hoses and gas equipment, reliance on unlicensed gas suppliers, and the storage of gas cylinders without a permit from the Department of Energy — all of which pose significant safety risks. However, these risks can be mitigated through stricter enforcement, certified installations, and increased public awareness. Thousands of inspections To safeguard lives and property, the DoE launched the second phase of its public awareness campaign promoting the safe and responsible use of LPG systems. Held under the slogan 'your safety is our priority', the campaign continues efforts initiated in 2024 and 2025 to reinforce regulatory compliance and embed a culture of safety. Ahmed Alsheebani, Executive Director of Regulatory Affairs for the Petroleum Products Sector, told Khaleej Times, 'We inspected more than 11,000 facilities as part of broader efforts to enhance compliance, encourage the safe use of gas, and instill a culture of safety and accountability across residential, commercial, and industrial sectors.' Precautions As part of the gas systems improvement initiative, the Department replaced 450 central gas tanks and control panels, installed over 10,000 gas leak detectors in buildings. It decommissioned outdated or duplicate systems in several properties to reduce risk. Alsheebani added 'This vital project significantly enhanced the safety of central gas systems across the emirate, through thorough assessments and necessary upgrades.' To ensure compliance, the DoE enforces a series of gas safety regulations. These include prohibiting the use of gas cylinders in buildings equipped with compliant central gas systems, ensuring proper ventilation and emergency exits in commercial kitchens, and mandating periodic maintenance by authorised service providers. Leaks must be reported immediately via emergency numbers 997. Requirements Commercial establishments, such as restaurants, must also maintain updated documentation, including: a Certificate of Conformity, a No-Objection Certificate, a Project Completion Certificate, an Annual Maintenance Contract, and a Civil Defense Safety and Prevention Compliance Certificate. Failure to comply could result in legal consequences, including potential closure. Adopting preventive practices The department advises families and food establishments to adopt preventive practices, like installing gas leak detectors, working only with authorised gas companies, and conducting regular safety checks. For instance, homeowners are encouraged to test for leaks by applying soapy water to gas connections — bubbles may indicate a leak — and to promptly replace any damaged hoses. Alsheebani stressed, 'If you smell gas, turn off the main valve immediately, ventilate the area, avoid turning on electrical switches or flames, and call emergency services or your gas provider.' Through its ongoing awareness campaign, the DoE is promoting safe gas use through a comprehensive outreach strategy. This includes digital campaigns in eight languages across social media platforms, SMS notifications in partnership with government entities, and the distribution of multilingual leaflets to food businesses. Additionally, the department is organising Gas Safety Majlis sessions and interactive workshops aimed at vulnerable groups, including labourers and kitchen workers, utilising educational tools like virtual reality to reinforce best safety practices and alter behaviour.
Yahoo
05-06-2025
- Business
- Yahoo
Regulatory Affairs Outsourcing Market Analysis Report 2025: Globalization of Biopharmaceutical and Medical Device Companies Bolster Growth - Trends, Opportunities, and Forecasts 2020-2030
Regulatory Affairs Outsourcing Market Dublin, June 05, 2025 (GLOBE NEWSWIRE) -- The "Regulatory Affairs Outsourcing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2020-2030F" report has been added to Regulatory Affairs Outsourcing Market was valued at USD 6.84 Billion in 2024, and is expected to reach USD 11.94 Billion by 2030, rising at a CAGR of 9.73% Market expansion is primarily driven by increased R&D efforts and a rising number of clinical trial applications and product registrations. Additionally, regulatory measures aimed at controlling drug costs are generating economic pressures that encourage life sciences companies to outsource regulatory functions. The COVID-19 pandemic further accelerated this trend, as the urgent development of vaccines underscored the importance of streamlined regulatory processes. As globalization continues, companies entering international markets face a complex web of regulatory standards, prompting greater reliance on external expertise to navigate compliance efficiently. This demand is especially strong in emerging markets where operational costs are lower and regulatory environments are increasingly attractive for Market Drivers Globalization of Biopharmaceutical and Medical Device CompaniesThe expansion of biopharmaceutical and medical device companies into international markets is a major driver behind the growth of regulatory affairs outsourcing. Each new market introduces unique compliance requirements, demanding specialized regulatory knowledge. Outsourcing helps companies manage these challenges efficiently and cost-effectively. Emerging regions such as Asia Pacific, Latin America, and the Middle East & Africa are particularly appealing due to lower development costs, skilled labor availability, and favorable regulatory climates. For instance, infrastructure investments like B. Braun's five new facilities in Malaysia and Flex Ltd.'s site in India reflect the trend of companies expanding regionally while leveraging outsourced regulatory expertise to ensure Market Challenges Data Security and Privacy ConcernsSecurity and privacy of sensitive regulatory information are critical challenges in this market. As outsourcing increases, so does the risk of data breaches and cyberattacks. The growing use of digital platforms - such as electronic Common Technical Document (eCTD) submissions and digital IND safety reporting - amplifies vulnerabilities. Additionally, mergers and acquisitions within the healthcare sector can expose organizations to greater cybersecurity threats due to the volume and sensitivity of exchanged data, posing a significant risk to business continuity and regulatory Market Trends Technological Advancements in Regulatory ProcessesTechnological progress is reshaping regulatory affairs outsourcing, introducing tools that enhance transparency, speed, and collaboration. Regulatory Information Management Systems (RIMS) are streamlining submission tracking and compliance monitoring. Cloud-based platforms enable real-time interaction between clients and service providers, improving operational efficiency. Furthermore, artificial intelligence (AI) and machine learning are being used to automate administrative tasks like data entry and document processing, allowing regulatory professionals to focus on strategic functions. These technologies are optimizing regulatory workflows, making it easier for companies to meet global compliance standards swiftly and accurately. Key Attributes: Report Attribute Details No. of Pages 180 Forecast Period 2024 - 2030 Estimated Market Value (USD) in 2024 $6.84 Billion Forecasted Market Value (USD) by 2030 $11.94 Billion Compound Annual Growth Rate 9.7% Regions Covered Global Report Scope: Competitive LandscapeCompany Profiles: Detailed analysis of the major companies present in the Global Regulatory Affairs Outsourcing Market. Accell Clinical Research, LLC. Genpact Ltd. CRITERIUM, INC. Promedica International. WuXi AppTec Co Ltd. Medpace Inc. Charles River Laboratories Inc. ICON plc. Covance, Inc. Parexel International Corporation. Regulatory Affairs Outsourcing Market, By Service: Regulatory Consulting Legal Representation Regulatory Writing & Publishing Product registration & clinical trial applications Regulatory Submissions Regulatory Operations Other services Regulatory Affairs Outsourcing Market, By Category: Pharmaceutical Medical Device Regulatory Affairs Outsourcing Market, By Company Size: Small Companies Medium Companies Large Companies Regulatory Affairs Outsourcing Market, By Indication: Oncology Neurology Cardiology Immunology Other Indications Regulatory Affairs Outsourcing Market, By Product Stage: Preclinical Clinical Premarket Approval Regulatory Affairs Outsourcing Market, By End Use: Medical Device Companies Pharmaceutical Companies Biotechnology Companies Regulatory Affairs Outsourcing Market, By Region: North America United States Canada Mexico Europe France Germany United Kingdom Italy Spain Asia Pacific China India Japan South Korea Australia South America Brazil Argentina Colombia Middle East & Africa South Africa Saudi Arabia UAE For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Attachment Regulatory Affairs Outsourcing Market CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
