Articles
The FDA review process for De Novo requests includes a thorough risk assessment of the medical device to determine its safety and effectiveness.
De Novo is an approach for the FDA to classify novel medical devices based on risk for devices whose safety and effectiveness can be ensured through general controls or specific controls (i.e., low and moderate risk). De Novo provides both a pathway to bring innovative devices to market and establishes a new classification standard that will inform the marketing of similar devices in the future. In this article, we will provide an overview of the De Novo request and the application process. What Is De Novo? De Novo is a way used by the FDA to regulate the marketing authorization of certain novel medical devices. These medical devices cannot demonst…
De Novo is an approach for the FDA to classify novel medical devices based on risk for devices whose safety and effectiveness can be ensured through general controls or specific controls (i.e., low and moderate risk). De Novo provides both a pathway to bring innovative devices to market and establishes a new classification standard that will inform the marketing of similar devices in the future. In this article, we will provide an overview of the De Novo request and the application process. What Is De Novo? De Novo is a way used by the FDA to regulate the marketing authorization of certain novel medical devices. These medical devices cannot demonst…
PLGA has been extensively employed as a carrier for drug delivery systems, facilitating the transport of therapeutic agents including proteins, peptides, DNA, and diverse anticancer drugs.
Introduction to PLGA as Microsphere Material Poly (lactic-co-glycolic acid) or PLGA is a co-polymer synthesized from lactic acid and glycolic acid, widely recognized for its exceptional biocompatibility and biodegradability. Owing to these desirable properties, PLGA has been extensively employed as a carrier for drug delivery systems, facilitating the transport of therapeutic agents including proteins, peptides, DNA, and diverse anticancer drugs. The flexibility in its application can be attributed to its modifiable properties. By manipulating the monomer ratio, molecular weight, concentration, and termin…
Introduction to PLGA as Microsphere Material Poly (lactic-co-glycolic acid) or PLGA is a co-polymer synthesized from lactic acid and glycolic acid, widely recognized for its exceptional biocompatibility and biodegradability. Owing to these desirable properties, PLGA has been extensively employed as a carrier for drug delivery systems, facilitating the transport of therapeutic agents including proteins, peptides, DNA, and diverse anticancer drugs. The flexibility in its application can be attributed to its modifiable properties. By manipulating the monomer ratio, molecular weight, concentration, and termin…
The increased development of biopharmaceuticals makes a growing demand for the sensitive and reliable quantification determination of proteins in complex biological matrices such as plasma and serum.
The increased development of biopharmaceuticals makes a growing demand for the sensitive and reliable quantification determination of proteins in complex biological matrices such as plasma and serum. The method for quantifying proteins in biological matrices is based on ligand binding assays (LBAs) before. Currently, liquid chromatography coupled to tandem mass spectrometry (LC–MS/MS) has been demonstrated that can be used for the quantification of proteins. One of the main strengths of the technique lies in the possibility to use internal standards that correct for different sources of analyti…
The increased development of biopharmaceuticals makes a growing demand for the sensitive and reliable quantification determination of proteins in complex biological matrices such as plasma and serum. The method for quantifying proteins in biological matrices is based on ligand binding assays (LBAs) before. Currently, liquid chromatography coupled to tandem mass spectrometry (LC–MS/MS) has been demonstrated that can be used for the quantification of proteins. One of the main strengths of the technique lies in the possibility to use internal standards that correct for different sources of analyti…
The average growth pattern predicts that the worldwide biochar market will reach USD 3,429.58 million in 2034. The analysis also anticipates that the market will develop at a compound annual growth rate (CAGR) of 16.2% between 2024 and 2034. According to projections, the global biochar market would generate USD 758.36 million by 2024.
The Biochar market is witnessing significant growth driven by its increasing use in agriculture, waste management, and environmental applications. Biochar is a carbon-rich, fine-grained substance obtained through the thermal decomposition of organic materials under limited oxygen conditions (pyrolysis). It offers multiple benefits, such as improving soil fertility, enhancing crop yield, reducing greenhouse gas emissions, and sequestering carbon. The global bio…
The Biochar market is witnessing significant growth driven by its increasing use in agriculture, waste management, and environmental applications. Biochar is a carbon-rich, fine-grained substance obtained through the thermal decomposition of organic materials under limited oxygen conditions (pyrolysis). It offers multiple benefits, such as improving soil fertility, enhancing crop yield, reducing greenhouse gas emissions, and sequestering carbon. The global bio…
Neuro-symbolic AI is a type of AI in which the algorithms mimic the structure and function of neural networks in human brains and recognize symbols associated with representations or relationships. In the pharmaceutical industry, neuro-symbolic AI can be especially helpful by enabling more effective drug repositioning, identifying appropriate patient cohorts more efficiently, and furthering personalized medicine.
Artificial intelligence has transformed many industries and processes, and some decision-makers are exploring how to apply AI to meet specific needs. They are also interested in how different types of AI could help them. Some business leaders have begun relying on neuro-symbolic AI. Its algorithms mimic the structure and function of neural networks in human brains and recognize sym…
Artificial intelligence has transformed many industries and processes, and some decision-makers are exploring how to apply AI to meet specific needs. They are also interested in how different types of AI could help them. Some business leaders have begun relying on neuro-symbolic AI. Its algorithms mimic the structure and function of neural networks in human brains and recognize sym…
With over 50,000 monthly searches querying mental health over the past year, Blue Monday - the so-called 'most depressing day of the year' - (20th January) highlights just how critical employee wellbeing has become for businesses. Digital PR agency Reboot Online analysed thousands of job adverts to identify the industries excelling - and struggling - in offering mental health benefits such as employee assistance programs and mental health first aid.
With over 50,000 monthly searches querying mental health over the past year, Blue Monday - the so-called 'most depressing day of the year' - (20th January) highlights just how critical employee wellbeing has become for businesses. Research shows that workplaces supporting mental health enjoy increased productivity and reduced absenteeism, empha…
With over 50,000 monthly searches querying mental health over the past year, Blue Monday - the so-called 'most depressing day of the year' - (20th January) highlights just how critical employee wellbeing has become for businesses. Research shows that workplaces supporting mental health enjoy increased productivity and reduced absenteeism, empha…
The global market for generative artificial intelligence in chemicals is anticipated to expand at a compound annual growth rate (CAGR) of 29.8% from 2025 to 2035. The market is anticipated to generate USD 14.75 billion in revenue by 2035, assuming an average growth trend. Global generative artificial intelligence in chemicals is expected to reach a value of USD 0.68 billion by 2025.
The Global Generative AI In Chemical Market is expected to grow at a compound annual growth rate (CAGR) of 29.8% between 2025 and 2035. Based on an average growth pattern, the market's revenue is expected to reach USD 14.75 billion in 2035. It is projected that the global market for generative artificial intelligence in chemicals will be worth USD 0.68 billion by 2025. Generative AI refers to a class of artifici…
The Global Generative AI In Chemical Market is expected to grow at a compound annual growth rate (CAGR) of 29.8% between 2025 and 2035. Based on an average growth pattern, the market's revenue is expected to reach USD 14.75 billion in 2035. It is projected that the global market for generative artificial intelligence in chemicals will be worth USD 0.68 billion by 2025. Generative AI refers to a class of artifici…
Medical Affairs plays a crucial role in bridging the gap between science and business in the pharmaceutical and life sciences industries. Amongst the many different career paths on offer within the field are two critical roles: the Medical Science Liaison (MSL) and the Medical Advisor.
Medical Affairs plays a crucial role in bridging the gap between science and business in the pharmaceutical and life sciences industries. Amongst the many different career paths on offer within the field are two critical roles: the Medical Science Liaison (MSL) and the Medical Advisor. Whilst these two roles share plenty of common ground, they differ significantly in both their functions are career trajectories, and in this article, we dive deeper into these differences.
Medical Affairs plays a crucial role in bridging the gap between science and business in the pharmaceutical and life sciences industries. Amongst the many different career paths on offer within the field are two critical roles: the Medical Science Liaison (MSL) and the Medical Advisor. Whilst these two roles share plenty of common ground, they differ significantly in both their functions are career trajectories, and in this article, we dive deeper into these differences.
Medical Affairs has become an increasingly critical function in the pharmaceutical and life sciences industries. Acting as the bridge between research, clinical development, and commercial teams, medical affairs professionals play a pivotal role in ensuring the scientific integrity and ethical promotion of medical products.
Medical Affairs has become an increasingly critical function in the pharmaceutical and life sciences industries. Acting as the bridge between research, clinical development, and commercial teams, medical affairs professionals play a pivotal role in ensuring the scientific integrity and ethical promotion of medical products. If you’re looking to transition into this field, then understanding the essential skills and qualifications needed to succeed is key. Read the full a…
Medical Affairs has become an increasingly critical function in the pharmaceutical and life sciences industries. Acting as the bridge between research, clinical development, and commercial teams, medical affairs professionals play a pivotal role in ensuring the scientific integrity and ethical promotion of medical products. If you’re looking to transition into this field, then understanding the essential skills and qualifications needed to succeed is key. Read the full a…
13-Jan-2025
Healthcare providers operate in a high-stakes environment where protecting sensitive patient data is critical. With increasing cybersecurity threats and complex compliance requirements, maintaining secure and reliable systems is a priority.
Healthcare providers operate in a high-stakes environment where protecting sensitive patient data is critical. With increasing cybersecurity threats and complex compliance requirements, maintaining secure and reliable systems is a priority. A SOC 2 audit helps healthcare organizations meet these challenges head-on by providing a structured framework for managing data security, privacy, and operational integrity. Here’s why SOC 2 audits are essential for healthcare providers and how they can strengthen security practices while supporting complia…
Healthcare providers operate in a high-stakes environment where protecting sensitive patient data is critical. With increasing cybersecurity threats and complex compliance requirements, maintaining secure and reliable systems is a priority. A SOC 2 audit helps healthcare organizations meet these challenges head-on by providing a structured framework for managing data security, privacy, and operational integrity. Here’s why SOC 2 audits are essential for healthcare providers and how they can strengthen security practices while supporting complia…
In 2025, advancements in manufacturing technology and polymer science are revolutionising the capsule industry, driving the widespread adoption of cellulose-based capsules. These innovations address raw material concerns, enhance API release and stability, and offer formulators significant advantages. As the limitations of gelatine become increasingly evident, scientists are leveraging modern technologies to optimise product development and adapt to shifting market demands.
Dr. Subhashis Chakraborty, General Manager, Head - Global Product Management, ACG Capsules – ACG “In 2025, advancements in manufacturing technology and polymer science are revolutionising the capsule industry, driving the widespread adoption of cellulose-based capsules. These innovations address raw material concerns, en…
Dr. Subhashis Chakraborty, General Manager, Head - Global Product Management, ACG Capsules – ACG “In 2025, advancements in manufacturing technology and polymer science are revolutionising the capsule industry, driving the widespread adoption of cellulose-based capsules. These innovations address raw material concerns, en…
The imaging technologies for precision agriculture market is expected to increase at a compound annual growth rate (CAGR) of 11.7% between 2025 and 2035. If the market continues on its current average growth trajectory, revenues are expected to reach USD 4.12 billion by 2035. By 2025, it is anticipated that the global market for imaging technology for precision agriculture will be valued at USD 1.29 billion.
The agriculture industry is undergoing a significant transformation driven by technological innovations. Among these, imaging technologies for precision agriculture stand out as game-changers, enabling farmers to enhance productivity, minimize costs, and adopt sustainable farming practices. The market for imaging technologies in precision agriculture is experiencing rapid growth, driv…
The agriculture industry is undergoing a significant transformation driven by technological innovations. Among these, imaging technologies for precision agriculture stand out as game-changers, enabling farmers to enhance productivity, minimize costs, and adopt sustainable farming practices. The market for imaging technologies in precision agriculture is experiencing rapid growth, driv…
From 2024 to 2034, the global market for circulating fluidized bed boilers is anticipated to develop at a compound annual growth rate (CAGR) of 3.7%. In 2034, the market is anticipated to reach USD 1,463.74 million based on an average development pattern. In 2024, the global market for circulating fluidized bed boilers is expected to generate USD 984.62 million in revenue.
The Global Circulating Fluidized Bed Boilers Market is expected to increase at a compound annual growth rate (CAGR) of 3.7% between 2024 and 2034. Based on an average growth pattern, the market is expected to reach USD 1,463.74 million in 2034. Revenue from the worldwide market for circulating fluidized bed boilers is projected to reach USD 984.62 million in 2024. Circulating Fluidized Bed (CFB) boilers are advanc…
The Global Circulating Fluidized Bed Boilers Market is expected to increase at a compound annual growth rate (CAGR) of 3.7% between 2024 and 2034. Based on an average growth pattern, the market is expected to reach USD 1,463.74 million in 2034. Revenue from the worldwide market for circulating fluidized bed boilers is projected to reach USD 984.62 million in 2024. Circulating Fluidized Bed (CFB) boilers are advanc…
In this article, we share our advice on how to get the most out of your pharma job search in 2025, with tips on how to navigate the challenges ahead and also seize the opportunities presented by AI and other evolving technologies.
New year, new job? If you’ve worked in the life sciences industry over the past few years, or have been trying to break into it, then you’ll already know that the 2023 and 2024 job markets haven’t been kind to us. Over the past year in particular, we’ve seen mass layoffs, restricted spending, delayed projects, skills shortages, increasing geopolitical tensions and unstable economies to name a few, all of which have created an extremely unpredictable landscape that has seen many companies across the industry invest in survival rather than growth. This has made for…
New year, new job? If you’ve worked in the life sciences industry over the past few years, or have been trying to break into it, then you’ll already know that the 2023 and 2024 job markets haven’t been kind to us. Over the past year in particular, we’ve seen mass layoffs, restricted spending, delayed projects, skills shortages, increasing geopolitical tensions and unstable economies to name a few, all of which have created an extremely unpredictable landscape that has seen many companies across the industry invest in survival rather than growth. This has made for…
As per Intent Market Research, the Animal Intestinal Health Market was valued at USD 4.5 billion in 2023 and will surpass USD 6.9 billion by 2030; growing at a CAGR of 6.3% during 2024 - 2030.
Air Traffic Control (ATC) Equipment Market As per Intent Market Research, the Air Traffic Control (ATC) Equipment Market was valued at USD 9.8 billion in 2023 and is projected to exceed USD 16.6 billion by 2030, growing at a CAGR of 7.8% during the forecast period of 2024 to 2030. This growth is driven by increasing air traffic, advancements in air traffic management technologies, and modernization initiatives in aviation infrastructure worldwide. Overview of ATC Equipment Market Air Traffic Control (ATC) equipment encompasses various systems, devices, and te…
Air Traffic Control (ATC) Equipment Market As per Intent Market Research, the Air Traffic Control (ATC) Equipment Market was valued at USD 9.8 billion in 2023 and is projected to exceed USD 16.6 billion by 2030, growing at a CAGR of 7.8% during the forecast period of 2024 to 2030. This growth is driven by increasing air traffic, advancements in air traffic management technologies, and modernization initiatives in aviation infrastructure worldwide. Overview of ATC Equipment Market Air Traffic Control (ATC) equipment encompasses various systems, devices, and te…
As per Intent Market Research, the Rabies Vaccine Market was valued at USD 1.6 billion in 2023 and will surpass USD 2.3 billion by 2030; growing at a CAGR of 5.7% during 2024 - 2030.
Rabies Vaccine Market As per Intent Market Research, the Rabies Vaccine Market was valued at USD 1.6 billion in 2023 and is projected to exceed USD 2.3 billion by 2030, growing at a CAGR of 5.7% during the forecast period of 2024 to 2030. This growth is attributed to increasing awareness about rabies prevention, rising vaccination initiatives, and the growing prevalence of animal bites globally. Overview of Rabies Vaccination Rabies is a deadly viral disease that affects the central nervous system. It is primarily transmitted through the bite or scratch of an infected animal.…
Rabies Vaccine Market As per Intent Market Research, the Rabies Vaccine Market was valued at USD 1.6 billion in 2023 and is projected to exceed USD 2.3 billion by 2030, growing at a CAGR of 5.7% during the forecast period of 2024 to 2030. This growth is attributed to increasing awareness about rabies prevention, rising vaccination initiatives, and the growing prevalence of animal bites globally. Overview of Rabies Vaccination Rabies is a deadly viral disease that affects the central nervous system. It is primarily transmitted through the bite or scratch of an infected animal.…
One of the frequently cited FDA inspectional observations for finished pharmaceuticals includes violations of Current Good Manufacturing Practice.
CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.
Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing labor…
Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing labor…
The US Food and Drug Administration (FDA) and the UK Medicines and Healthcare Regulatory Agency (MHRA) both publish Out of Specification Investigation Guidance documents for the pharmaceutical industry.
Both regulatory bodies' guidances specify investigation processes that are virtually the same, with only minor changes that do not have a significant impact on the common approach being pushed. Following the procedures outlined in either is considered to be compliant with both, though it is helpful to be aware of the minor distinctions.
The investigation approach should be the same for analytical results that are OOS, or indeed for any result that is outside the regular pattern of results, according to both US and UK regulations (often referred to as atypical results). It is critical…
The investigation approach should be the same for analytical results that are OOS, or indeed for any result that is outside the regular pattern of results, according to both US and UK regulations (often referred to as atypical results). It is critical…
Some impressive qualities that make it a game-changer for delivering essential calcium to our body. Let us explore into the three main reasons why Calcium Lactate Gluconates is fast becoming everyone’s darling
Let’s face it—taking calcium supplements can be a little bit of a drag. The swallowing of chalky pills or dealing with an upset stomach do not exactly make one excited about health. Consider a world in which taking calcium supplements does not result in a gritty aftertaste or where fortifying our favorite drink with calcium does not turn them cloudy. That is where calcium lactate gluconate comes in, which has come as the superman of calcium in town because it is water soluble. Different from its chalky relative, calcium carbonate, this particular salt of calcium has got an incredible…
Let’s face it—taking calcium supplements can be a little bit of a drag. The swallowing of chalky pills or dealing with an upset stomach do not exactly make one excited about health. Consider a world in which taking calcium supplements does not result in a gritty aftertaste or where fortifying our favorite drink with calcium does not turn them cloudy. That is where calcium lactate gluconate comes in, which has come as the superman of calcium in town because it is water soluble. Different from its chalky relative, calcium carbonate, this particular salt of calcium has got an incredible…
The global anti-aging market is rapidly expanding as advancements in science, technology, and biotechnology make age-defying solutions more accessible to a broader demographic. Valued at approximately USD 195.9 billion in 2023, this market is projected to reach USD 381.2 billion by 2032, with a compounded annual growth rate (CAGR) of 7.8% from 2024 to 2032. The increasing demand for anti-aging products is driven by various factors including demographic shifts, enhanced consumer awareness, and a growing preference for preventive healthcare solutions. This article delves deep into the market dynamics, key drivers, challenges, and opportunities, along with a detailed market segmentation analysis.
The global anti-aging market is experiencing unprecedented growth, with an estimated market size o…
The global anti-aging market is experiencing unprecedented growth, with an estimated market size o…
