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November 2021

Digital Solutions in Drug Development

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Digital Solutions in Drug Development

R&D is important in the pharmaceutical industry because it promotes innovative production methods, lowers medicine costs and improves product quality. Additionally, research and development may recruit highly-skilled, creative and innovative workers and play a critical role in the innovation process, particularly in the pharmaceutical industry. The research and development process is critical to the pharmaceutical industry’s drug development process. The process begins with identifying a potential candidate drug and is followed by intensive research testing to determine the medicine’s therapeutic suitability.


The pharmaceutical industry is concerned with human lives since it creates and manufactures miracle medicines for people. Diseases are becoming more prevalent as a result of pollution and changes in people’s eating habits. Nowadays, nearly everyone is afflicted with at least one disease, whether an infection or a viral illness. Additionally, as a consequence of pollution, people are afflicted with a variety of skin problems. All of these conditions classify people as patients. As a consequence, medicine has become a regular meal for many people.

Research & Development

All companies rely on research and development. In the biopharmaceutical research industry, R&D services generate revenue for the companies participating in the study by saving or improving patients’ lives. Pharmaceutical research and development are important components of many businesses’ success; doctors and scientists from every country have made substantial expenditures in the study and development of this sector. Reliable pharmaceutical research and development services enable businesses to adhere to manufacturing procedures, quality control measures, production scope and technical expertise.

Digital Solutions in Drug Development

From mobile medical apps and fitness trackers to software that aids doctors in their daily clinical decisions, digital technology has sparked a revolution in healthcare. As we adjust to the new normal brought about by the COVID pandemic, the use of digital solutions has grown.

Pharmaceutical Process Development

Process development is the process of creating, implementing, or improving an existing industrial process. It ensures that a product can be manufactured aseptically and consistently to meet requirements before mass production. Furthermore, it creates a minimal industrial strategy by translating methods developed on the bench in a research lab to industrial-scale life-cycle studies that consider needed improvements in a controlled environment, equipment and auxiliary materials.


This process also evaluates the manufacturing feasibility of each project and sets quality and testing criteria for production-process controls and released products. We may create new processes, transfer old processes, or enhance existing processes from the start of development. The goal is to reduce the risk of developing a final advanced treatment pharmaceutical product, whether via an end-to-end process or by optimizing certain phases.

Research and Development on the Demand Side | Rondaxe

Research and Development on the Demand Side

Drug prices in a market economy would be determined by supply and demand. Because most of the cost of producing medications is spent on research and development rather than manufacturing pills, the government is mainly concerned with providing patent protection and exclusivity to foster sustainable innovation. The amount of money spent on developing new medicines is contingent upon the capacity to reach this pricing.

Suppose health insurance pays for a significant portion of the cost of medications. In that case, manufacturers may charge higher rates and will almost certainly invest more in the research and development of new therapies. On the other hand, increased price leads to a decrease in the number of units sold of the medicine. As a result of this supply constraint, investment is very sensitive to value; in other words, what a medicine accomplishes medically vs. how much it costs.


However, three significant developments in recent years have changed the demand constraint. To begin, more people now have access to prescription medication coverage due to Medicare Part D and the expansion of insurance coverage under the Affordable Care Act. Second, drug insurance has become much more comprehensive due to the introduction of benefit designs that limit the enrollee’s out-of-pocket costs. Third, the cost of many contemporary medications is too high, such as particularly specialized pharmaceuticals used to treat complex, chronic illnesses like cancer, rheumatoid arthritis and multiple sclerosis. This component affects demand as a result of its interactions with various insurance benefit design elements.

Consider the case when a patient is using a $50 medication, and a new, possibly better therapy becomes available for $100. In such cases, insurance benefit designs often allow the patient to take the newer medicine at a higher cost (with the permission of a prescribing physician). While the patient’s cost is less than the difference in the prices of the two medications, only those who believe they will benefit from switching will do so.


When annual expenses exceed $100,000 or $200,000, however, everything changes. The majority of patients who are forced to pay a significant portion of the cost of these medications will never get the prescription. On the other hand, out-of-pocket maximums make medications affordable, and as a result, the patient becomes oblivious to price differences. Ultimately, the patient pays the same amount for medications that cost $100,000 or $200,000—their out-of-pocket maximum. This indicates that cost increases at this level do not affect patient demand.


Due to current insurance programs and the high cost of medications, rising prices may not result in fewer units. On the contrary, since new medications are anticipated to be profitable, revenues will likely rise, as will investment in their development.

More information on research and development can be found online at

Pharmaceutical Technology Transfer Process

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Pharmaceutical Technology Transfer Process | Rondaxe


It is vital to impart critical technology and knowledge to ensure the continuous manufacture of high-quality drugs. This procedure is known as technology transfer, and it is the process of bringing a concept from the lab to the market.


In the pharmaceutical industry, the term “technology transfer” refers to all of the processes required for successful development, from medicine discovery through product improvement, clinical trials and final commercialization. Additionally, it is sometimes understood how technology inventors make their technology accessible to commercial partners who subsequently utilize it.

The Process of Technology Transfer

Transfer of technology is critical and vital to medication research and development for new pharmaceutical products. Economic factors often influence the choice to transfer such products across manufacturing sites. The procedure is divided into the following phases:


  • Data collection
  • Data review
  • Regulatory impact (more emphasis on change approvals)
  • Analytical validation
  • Pilot or total process batch
  • Stability setdown


The discovery and development of medications in a typical research-based pharmaceutical company may be split into two phases: research and development.


The research phase is primarily concerned with conducting scientific investigations that will develop new services and products that will benefit the public. The process then progresses to the development phase. Additional research is done to evaluate the product’s economic viability and conduct a market study to establish if a consumer need exists. Once research demonstrates economic viability, it is protected by filing for intellectual property protection. Commercialization happens after licensing when the service or product is offered to the market; this is the last step, the stage of production. Additionally, feedback from advertised products is considered.


The stages of formulation are:


  • Pre-formulation studies
  • Bench-scale- 1/1000th of Y
  • Lab-scale – 1/100th of Y
  • Scale up – 1/10th of Y
  • Commercial – Y


Where Y is final commercial scale lot size

Importance of Technology Transfer

Technology transfer reveals critical information for transferring technology from R&D to manufacturing by sifting through data collected during R&D; to explain essential information to facilitate the transfer of technology for products in stock across several manufacturing sites; and to illustrate particular areas of concern and procedures, thus facilitating the smooth transfer of technology.

Ensuring a Successful Technology Transfer | Rondaxe

Certain issues should be discussed to facilitate the transfer of pharmaceutical technology. The following are some examples:


  • A safety and health evaluation should be undertaken to guarantee that the products can be handled properly;
  • Validation of cleaning procedures must be conducted. Additionally, batch records and requirements must be recorded correctly;
  • Packaging line trials should be conducted, particularly if the facility is new to the product. By defining stability methods, online transfers against customer-approved processes should be permitted;
  • Operators must be trained, and quality assurance agreements must be in place. Additionally, timelines should be followed, and significant issues and occurrences should be communicated.


More information on the technology transfer process is readily available at


Pharmaceutical Industry Research And Development

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Pharmaceutical-Industry-Research And Development | Rondaxe

Each year, the pharmaceutical industry in the United States develops several new medications with substantial medical benefits. Unfortunately, many of these medications are expensive, leading to rising healthcare costs for the private and public sectors. Policymakers have looked at ways to reduce the cost of medications and government drug expenditure, and such restrictions would very likely reduce the pharmaceutical industry’s incentive to do new research.


In one study, the Congressional Budget Office (CBO) analyzes changes in pharmaceutical research and development (R&D) spending as well as the introduction of new medications. Additionally, the CBO examines the following factors that affect how much money pharmaceutical companies spend on research and development:


  • Anticipated worldwide profits from a new medication
  • Cost of developing a new drug
  • Government regulations that impact drug demand or supply (or both)

What are the Latest Trends in Pharmaceutical R&D and New Drug Approvals?

In 2019, the pharmaceutical sector invested $83 billion in research and development. These expenses were spent for various purposes including the discovery and testing of novel medications, the creation of incremental enhancements such as product expansions, and clinical testing for safety and marketing purposes. After inflation is considered, the total is about 10 times what the industry spent annually in the 1980s.

Additionally, pharmaceutical companies’ proportion of revenue spent on research and development has increased: Pharmaceutical companies spent almost a quarter of their revenues (net of expenses and buyer rebates) on research and development in 2019, nearly twice as much as they did in 2000. This revenue proportion is much higher than other knowledge-based industries such as semiconductors, specialized hardware and software.


Each year, the number of new medications approved has risen during the past decade. For example, from 2010 to 2019, the Food and Drug Administration (FDA) authorized an average of 38 new medicines each year (with a peak of 59 in 2018), a rate 60% greater than the average during the previous decade.


Numerous medications approved in the last few years have been categorized as “specialty drugs”. Specialty medications often treat chronic, difficult, or unusual illnesses that need specialized patient care or monitoring. Numerous specialty medications are biologicals (large-molecule pharmaceuticals derived from living cell lines), which are difficult to manufacture, duplicate and are often prohibitively expensive. Until recently, the majority of medications were composed of tiny molecules derived from chemical components. Even though they retained their patent protection, these medications were less costly than more modern specialized drugs. According to data on the kinds of medications now undergoing clinical trials, most of the industry’s creative effort is directed toward specialty pharmaceuticals that may provide new cancer therapies and treatments for nervous system illnesses such as Alzheimer’s and Parkinson’s disease.

What Factors Affect Research and Development Spending?

Three major factors affect pharmaceutical firms’ R&D expenditure decisions: anticipated expenses of developing new medication; global lifetime revenue projections for a new medication; and policies and initiatives affecting the supply and demand for prescription drugs.


Numerous variables affect companies’ expectations for a drug’s revenue stream, including the expected pricing in different countries and the estimated worldwide sales volume at those rates (given the potential number of persons who may use the medicine). Additionally, current pharmaceutical prices and sales volumes provide insight into customers’ desires and insurance plans’ readiness to pay for pharmacological treatments. Notably, when pharmaceutical companies set the price of a new medicine, they seek to maximize future revenues after subtracting manufacturing and distribution costs. Thus, a drug’s sunk R&D expenses—that is, the money spent earlier on developing the drug—does not affect its price.

Trends in R&D Spending and New Drug Development

Private investment in pharmaceutical research and development (and approval of new medications) has increased significantly in recent years, continuing a decades-long trend that was halted in 2008 by the availability of generic versions of several top-selling medications, as well as the 2007–2009 recession. Spending on pharmaceutical research and development, for example, increased by almost 50% between 2015 and 2019. Additionally, many medications approved in recent years are costly specialist therapies with a small patient population. On the other hand, the best-selling medications of the 1990s were low-cost pharmaceuticals with large patient populations.

R&D Spending

R&D expenditures in the pharmaceutical industry include a wide variety of activities, including the following:


  • The invention or the study and development of pharmaceuticals;
  • Clinical research and development, preparation and submission of FDA approval applications, and design of manufacturing processes for new medicines;
  • Incremental innovations including the development of novel dosage forms and delivery systems for existing medications and evaluating those medications for new purposes;
  • Product differentiation, or the clinical comparison of a novel medication to an existing competitor drug to demonstrate that the new medication is superior; and 
  • Safety monitoring, which the FDA may require to identify adverse effects that were missed during the drug’s development in shorter trials.


Private investment in pharmaceutical research and development by Pharmaceutical Research and Manufacturers of America (PhRMA) member firms was about $83 billion in 2019, up from approximately $5 billion in 1980 and $38 billion in 2000. Although those totals omit many smaller pharmaceutical companies that are not PhRMA members, the trend reflects the industry’s R&D expenditures. Additionally, a National Science Foundation (NSF) analysis of all pharmaceutical R&D spending in the United States (including smaller firms) reveals similar trends.


While total R&D spending by pharmaceutical firms has increased, small and large enterprises generally focus on distinct R&D activities. For example, small companies that are not members of PhRMA devote a greater part of their research to developing and testing new medications, the majority of which are ultimately acquired by larger corporations. On the other hand, larger pharmaceutical companies (including those in the PhRMA) devote a greater proportion of their R&D budgets to conducting clinical trials, developing incremental “line extension” improvements (new dosages or delivery systems, or new combinations of two or more currently available medications, for example), and conducting post-approval testing for safety monitoring or marketing purposes.

To find out more about research and development, visit Rondaxe online today.



Pharmaceutical Consulting Firms: Transforming the Pharma Industry

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Pharmaceutical Consulting Firms | Rondaxe

The FDA is beginning to tighten its compliance standards, resulting in a substantial increase in demand for pharmaceutical consulting services. Additionally, a manufacturer may profit from hiring a consulting firm in various ways since the firm will function as a sounding board in times of crisis.


Typically, pharmaceutical consulting companies would employ a broad group of specialists with specific knowledge in different facets of the pharmaceutical industry. One of the main objectives of this kind of consulting is to help manufacturers of medical devices and pharmaceutical medications comprehend their compliance responsibilities regarding the manufacturing processes used in their facilities. Additionally, an increasing number of manufacturers are struggling to comply with FDA regulations and therefore seek assistance from consulting companies to assist them.

Is Pharma Consulting the Right Solution for You?

While consulting offers many benefits, deciding if it is the right choice for your particular requirements involves discussing your situation with experts in the field. For instance, if you explain the kind of pharmaceutical goods you produce and your target market, it will be much easier for pharma consulting firms to develop a solution that fits your requirements.


Pharmaceutical training seminars are another often-requested resource from consulting companies, due to their high value. They contribute substantially to the knowledge base of workers and management on topics such as good manufacturing practices (GMP) and FDA / GMP audits. Finding the ideal pharmaceutical consulting team should be quite simple. Most manufacturers do online research to determine which consultants are the greatest match for their budget and consultant quality criteria.


Pharma consultancy is not a new concept in the pharmaceutical industry. Nonetheless, it is beginning to pay dividends for businesses that have been entangled in a sea of compliance and rules. Consequently, any manufacturer of medical equipment or medications would be prudent to seek the assistance of a respected consulting firm.

Pharma Consulting Uptake on the Increase

Utilizing pharmaceutical consulting companies may significantly enhance a pharmaceutical manufacturer’s compliance record. Given the benefits of using pharmaceutical consulting companies, it’s unsurprising that their use is increasing.


Pharma consulting companies are not uncommon in the medical device and supplement industries. Furthermore, the quality of the training programs and the consultants’ expertise has elevated them to an essential resource that businesses seeking to enhance their performance and compliance in the pharmaceutical sector cannot afford to ignore. Pharmaceutical consulting firms can enhance the production processes for medical devices and supplements. It is the responsibility of the professionals in this sector to contribute to the overall safety of the products that reach the market.

Speaking to Consulting Firms about FDA Compliance | Rondeaxe

Speaking to Consulting Firms about FDA Compliance

FDA compliance is undeniably one of the most serious problems plaguing the pharmaceutical business, and it plays a major role in manufacturers’ operations being harmed. As a result, manufacturers would certainly benefit from exploring the services of consulting firms, as their pharmaceutical consultants possess the necessary expertise to help them in resolving any FDA compliance issues that may arise.


It is essential to get the most out of consulting companies, including them early in the design and production phases. By doing so, you can help guarantee that they have the opportunity to examine the products you produce and give you any necessary advice about FDA compliance or good manufacturing practice (GMP) problems that may arise.


Consulting services will benefit manufacturers of all sizes, regardless of the pharmaceutical products manufactured; their expert analysis and thorough knowledge of how the business operates will allow a pharmaceutical goods manufacturer to thrive.

To find out how your company can benefit from pharmaceutical consulting, give Rondaxe a call at (315) 469-2800 today.