How to choose Pharmaceutical regulatory consulting services?
When your pharmaceutical company is working on a new project to develop new medicines, in this scenario, all they need is to take help from the pharmaceutical regulatory consulting company so that the project cannot face any burdens at this precious time. So, whenever you are choosing a pharmaceutical regulatory company that will help you out. Now, there are a number of consulting firms in the market, among them, if you want to choose the best team for you, here are some steps or actions that need to be considered so that you will be able to gain the best results.
1. Make sure they have recent industry experience: When you are searching for a Pharmaceutical regulatory consulting company, make sure that they have industry experience and recently and have a lot of experience in the market. It is also essential to know about the industry experience and much more. So, when you want to get the best results with the pharmaceutical regulatory company's help, this is the first face that you should search for at least once.
2. They have knowledge of the framework: When you are searching for a consulting company, it is going to be another step that you should take care of. When the company is able to know about the framework correctly, they will be able to assist you the most. When you can choose the right company, they will help you have a proper outcome from your business. So, you can also go for this method when it comes to making the best framework for you.
3. They are successful:
According to their past success, you can also choose from the companies. When they have past experience and a successful experience to complete a project, they will also help you to make your project successful. This is also denoted as a complete method to get complete success for your next project. So, at the time when you are trying to plan a new project to develop medicines, you can go for the success check at least once so that you will be successful in your next project.
Conclusion
Here are some practical steps that you should choose so that you will be able to gain much-needed help from the industry and the company. It is also denoted as a much-needed step that is really important for the industry. Hopefully, it will help your company to get success.
Source:
https://pharmdevgroup.com/how-to-choose-pharmaceutical-regulatory-consulting-services/
Four crucial steps to developing a drug according to FDA
If you don’t know, the development process of new drugs is not as easy as it may sound. Most pharmaceutical companies can take between 12 and 15 years from starting to research an active ingredient until it is available to patients. It is a very extensive process that requires a high economic investment by pharmaceutical companies. Mainly the process can be summarized in 5 steps.
Discovery and development
Therapeutic targets that indicate the development are identified in the very first stage. Targets are chemical substances that are associated with disease. Once the target has been identified, its mechanism is studied. Following this analysis, various tests are performed to see which compounds have the desired effect on the selected target.
Pre-clinical research
Before testing in humans, researchers must ensure that the compound is safe for human consumption. For this, studies are carried out in the laboratory such as -
• In vitro: these are studies that are performed on cells or tissues from glass or plastic containers.
• In vivo: these are tests that are carried out in the body of living organisms.
Pre-clinical research should provide detailed information on the possible doses that can be administered and the levels of toxicity. After these results, the researchers evaluate whether the drug candidate can be tested in humans.
Clinical research
Clinical research refers to studies or trials that are carried out on human beings to test how the drug interacts in the human body. Before starting this phase, researchers must deliver to regulatory agents the IND document, where the results of the pre-clinical research and the protocol of the clinical trial in humans to be carried out are presented. Clinical trials are conducted in phases (4 phases) ranging from small to large scale.
Registration and authorization of the authorities
Once the researchers have the results and analysis of the clinical trials, they proceed to send the NDA to the corresponding regulatory authorities. The NDA contains all the information about the drug where its safety and efficacy are demonstrated in the population studied. If the authorities see the safety, efficacy and quality of the new treatment proven, authorization is granted to market it. Once the product is marketed, new clinical trials can be carried out to determine its effectiveness for other indications.
If you are an owner of a pharmaceutical store, and are looking for new clients, search online and hire the best Pharmaceutical strategy consulting services to secure contracts and supply medical products and equipment.
Source:
https://www.bloglovin.com/@aaryan27/four-crucial-steps-to-developing-a-drug-according
Why choose a Regulatory Affairs Company online?
Today we are going to tell you about the advantages of choosing professional Regulatory affairs services to regularize and host your products. Exporting your products can be a great growth opportunity. The geo-political demand created a favorable scenario for the economic growth and therefore, the expectation is that the GDP will grow and warm the international market.
However, to sell your pharmaceutical products, you need to choose a regulatory affairs agency. Learn now the main advantages of a local company when it comes to regularizing products.
What is a regulatory affairs company for?
When a company or an entrepreneur wants to market its pharmaceutical products, it is necessary to be duly legalized in the country. Subsequently, the applicant companies must still be registered and notified before the right entity.
Only after the publication of the approval of the application for registration, the company can manufacture, import, and market its products. However, this whole process is not so simple and easy to do in case of inexperience of those involved. Therefore, it is essential that you hire a professional regulatory affairs company that has quality and experience in full technical and legal support, for obtaining and altering the registry plus the various regulated areas. The company that hires a regulatory affairs company will have its registration process faster and smoother.
Regulatory affairs company – bigger proximity to the market
By hiring a regulatory affairs agency, you bring along with the contract, the proximity to the country's market and as a result, the understanding of experts on trade. Besides helping you with the regulatory affairs factor, the company can also help you with sales and market advice in general to guarantee greater assertiveness in your business.
Greater proximity to regulatory bodies
Choosing a regulatory affairs agency makes the registration approval process much easier. By having vast experience and bureaucratic understanding, all regulatory procedures are faster and with less bureaucracy. What happens is that, when it comes to hosting products, some regulatory bodies may request documents or certifications that must be shown in a specific and short period of time. By hiring the professional services, you run business process specialized in entire legislation and regulations.
Conclusion
An essential and indispensable characteristic that regulatory affairs personnel must have is to know and be able to relate and communicate with the authority in the best way, as well as with their internal clients, to avoid confusion. All this will help to design a very good and accurate regulatory strategy, contributing to the achievement of the company's objectives.
EMA DRUG POST-MARKETING SAFETY SURVEILLANCE CHANGES, US IMPACT AND COMPLIANCE ASSISTANCE
On November 22, 2017, EMA launches a “new and improved” version of EudraVigilance (analogous to FDA Medwatch program). The result will be a total transition in the way that Individual case safety reports (ICSRs) are tracked and reported throughout Europe. ICSRs will be reported to the EudraVigilance database in the E2B(R3) format, replacing the E2B(R2) format.
Similar safety surveillance changes are on the way in the U.S.
As recently as April 2017, FDA noted that it intends to implement these safety-surveillance changes in the US at Q2 2019* and guidance was issued in February 2014.
*International Council for Harmonisation, US FDA, and Health Canada Regional Public Consultation April 24, 2017.
Impact on drug sponsors expected to be significant
The impact on drug sponsors’ adverse event reporting and data collection is expected to be significant. Overhaul of multiple ICSR processes and procedures will be required to implement the new standards in time for a rapidly approaching deadline. Transition planning should be undertaken immediately. According to Quintiles “The R2 format had 271 unique data elements with the average file using 120-150 of them. In R3, there are 333 unique data elements — 38 of which are new, and 33 of which have been altered.”
A logical and sound approach to compliance assistance
PDG® has significant experience in clinical trial design and safety reporting, post-marketing safety surveillance, and overall pharmacovigilance. This includes development and implementation of systems to include electronic data capture and reporting, SOPs, intake, standardized letters, periodic reporting, medical assessments and labeling changes. We start by asking our clients to complete a questionnaire in order to identify gaps. The balance of this paper describes our approach to implementing, auditing pharmacovigilance systems, or simply providing supplemental assistance.
Standard Operating Procedures (SOPs)
Drawing on our years of experience, PDG initially reviews and/or prepares SOPs incorporating organization, infrastructure, and pharmacovigilance related workflows. Included are processes for intake, handling, escalation and coding/reporting of adverse events, complaint handling, medical inquiries and labeling currency. Also addressed are commonly occurring issues and concerns such as medical emergencies, child safety, medication errors, overdose, lack of equivalence, recalls, safety related labeling changes and other consumer/prescriber communications. Integration with the overall quality system is critical. Always included is an SOP for maintaining currency with regulations, guidances, standards and other best practices e.g. preparation for conversion to E2B (3R).
Intake
PDG maintains a staff of regulatory affairs professionals on call 24/7/365 to accept both verbal and written adverse event reports. We also have affiliated call centers located at strategic points around the world. Our staff and affiliates are well versed in receipt, processing, narrative generation, MedDRA coding, medical review and submission to FAERS, including 15-day reporting. This includes literature reports which we routinely monitor for both 15-day reports and periodic safety reporting (PADERs and/or PSURs). Those reports requiring immediate attention are addressed accordingly, with all others processed the next business day. Staff are trained on client SOPs and always have immediate access to clinicians as needed.
Periodic Reporting
As noted, PDG prepares PADERs and PSURs and will submit to the applicable regulatory agency, or provides to the client in a format suitable for electronic submission. In doing so, we monitor the literature for potential 15-day reports. Each report will include the standard regulatory requirements (e.g. narrative summary and analysis of the information in the report, analysis of the 15-day reports submitted during the reporting interval, history of actions taken since the last report because of adverse drug experiences).
Adverse Event Database
Your database is critical for a multitude of reasons e.g. data mining/signal detection, post-marketing safety studies (voluntary or required), electronic data transmission among others. In a recent guidance, FDA noted that “A robust safety database is critically important to accurately assess and adequately characterize the risks of a new drug. Sponsors collect extensive safety-related data throughout the course of drug development, and knowledge about a drug’s safety profile continually evolves as safety data accumulate.”
We help our clients by preparing for changes such as the impending conversion from E2B(R2) to E2B(R3). If you believe your database is inadequate or on the verge of being outdated, or you believe outsourcing certain of the efforts may be advantageous, let us know.
Standard Letters
As with the SOPs, we draw upon our years of experience to develop templates to facilitate drafting responses to medical inquiries as they occur. Source materials include product labeling, review of the scientific literature, FAERS database and other relevant public sources (e.g. FDA, other regulatory authorities). Inquiries may be addressed by either of our medical teams as they occur. Examples of templates may include most frequently occurring events, information relating to vulnerable sub-populations such as pediatrics, geriatric or any others that might be expected to use the drug product.
Medical Quality
The President of PDG is a longstanding member of the faculty at a well-known medical school. She has also designed and placed a multitude of clinical trials, including sourcing of primary investigators. As such, PDG has various clinicians with drug safety and adverse event assessment experience on the team. We dedicate a clinician to your project who will review all necessary ICSRs, and all medical templates developed by the PDG research team. A back-up clinician is also assigned and stays fully briefed, to help ensure program continuity and responsiveness should the primary clinician become unavailable. Both will be knowledgeable in the prescribing information and client SOPs and will know the others on the team.
Conclusion
Whether you need to implement your first pharmacovigilance system, upgrade your existing system or outsource some or all of it, feel free to contact PDG® for assistance. As noted above, we have significant experience in clinical trial safety reporting, post-marketing safety surveillance and overall pharmacovigilance.
About the Authors
Charles Jaap is Vice-President of Operations and Business Development for PDG®, a global pharmaceutical and medical device consultant with extensive experience in the strategic development of drug products and medical devices.
Source:
https://pharmdevgroup.com/drug-post-marketing-safety-surveillance-changes-compliance-assistance/
Medical device consultants For Your Medical Device Business
As professionals in the health area, Medical device consultants have the responsibility to know the health regulation and apply it to comply with it, thus favouring regulatory processes, exercising our profession with responsibility.
The US market constitutes approximately 46% of the world market for medical devices, IVDs, cosmetics, biocides and PMCs.
Companies have generally addressed the approach to the marketing of medical devices, IVDs, cosmetics, biocides and PMCs in the United States by entrusting the task of obtaining FDA approval to the first retailer or agent with whom an agreement has been entered into. Commercial collaboration. In this case, there are not a few hidden pitfalls behind this choice. The main one concerns the ownership of the “FDA certification”, which will not belong to the manufacturer but the local dealer.
Role of Medical device consultants
Many medical devices require a substantial equivalence letter from the FDA stating that the device intended for sale is as safe and effective as other similar devices on the market. This is obtained by requesting premarket approval (501k). Medical device consultants can assist your company in the application process. High-risk under Class III devices require premarket approval by the FDA before they can be sold in the US. This can be a complicated process, as it requires the submission of clinical evidence of safety and the effectiveness of the device. Medical device consultants offer a full pre-market approval application service that ensuring your application meets all FDA requirements.
For devices intended for use in the treatment or management of patients with rare diseases, it may be challenging to meet the requirements for pre-marketing approval, as there is limited clinical evidence. In cases like these, the Humanitarian Devices Exemption (HDE) may be granted. Can help your business apply for HDE.
To meet the requirements for premarket approval, clinical trials of medical devices must be conducted. There is a special permission for the use and sale of devices in this context, known as the “Research Device Exemption” (IDE). Medical device consultants can help your business apply for this exemption.
Brand new devices are automatically classified as Class III devices as it is not possible to complete an equivalence assessment with other devices. If your device poses a low risk, you can prove it to the FDA. Medical device consultants can help your business through this process to ensure your device is classified as quickly as possible.
- New Records
- Technical Modifications
- Administrative
- Extensions
- High Techno vigilance
- Techno vigilance Report
Source:
Get the best NDA consulting services at Pharmaceutical Development Group
Changing lifestyle and eating habits in this current season brings some health challenges as well. Coping with this health disaster is not under the control of every person. Therefore, the invention and research of new medicine is a must to get rid of severe health calamity. All-time, you do not follow the concept of prevention is better than cure.
The particular disease can spot to you as you will tell the experienced discomfort in your body to doctor. Changing lifestyle and eating habits in this current season brings some health challenges as well. Coping with this health disaster is not under the control of every person. Therefore, the invention and research of new medicine is a must to get rid of severe health calamity. All-time, you do not follow the concept of prevention is better than cure. The particular disease can spot to you as you will tell the experienced discomfort in your body to doctor.
Having checked up on the specific pathological center, they will portray the full assessment of the body with absolute calculation. In case these professionals are keen to develop the new medicine to prevent an epidemic, then they must consider the best NDA consulting service. The demand for this consulting service is certain for new drug approval. So, nobody can raise the question of the development of this chemical substance for well-being.]
Why manufacturing company needs NDA consulting? None of the pharmaceutical companies can easily tell that their innovative idea and research ensure the exact formulation of a drug to deal with wellness queries. It is likely to have a flat affect of new medicine for a particular disease. So, the expert discusses for deserved change in the composition of the medicine. They are keen to interchange the valued ingredient with the most valued one. But, it does not mean that you would have to spend much money on its manufacturing cost.
Benefits of NDA consulting
Being a pharmaceutical company, NDA consulting helps you to outgrow your medicine business. It is a positive approach to how impartial objective, companies’ objective helps to provide patient access for that medicine.
- By admitting the NDA consulting in your new drug formulation, you can easily work on a single partner to reduce the cost of man-power engagement. The consultant helps you with the regulatory and reimbursement in a public place.
- The NDA has no clinical research professionals and further interest in doing unnecessary clinical research. We focus on this fact what you require and what you can do.
- Are you running a pharmaceutical company? Well, it is certain to do some new invention to bring a new medicine to the market. If you are interested to take NDA consulting service, then you do not need to go here and there. Nothing needs to do and make a deep research on the internet database. You will come in the connection of many consulting companies, but you can stop your discovery for NDA consulting to market your medical product in a short time. To know more information, you can surf our web address.
A Note on Pharmaceutical Industry News
The industry of pharmaceutical is one of the biggest industrial business management throughout the world. In the periods of overwhelming in the business market of the industrial level, this one can survive through every kind of hurdle as the needs of medicines are getting higher and higher of loads. The human world is now very familiar with the medical and pharmaceutical franchise companies as the growing medicine industries and the prosperity in medical science no doubt giving good statics of upward strike in a gradually increasing prosperous industry.
The services along with this business module are getting a massive quantity of responses and needs from the customer society. Without medicines, the present world is like the broken spine, as the climate and the atmospheric balance are decreasing day by day, so to be prepared to resist any unwanted disease in the body we have to be dependent on the medical world or the pharm industrial companies.
So just like any other industry, the pharma industry also contains daily hot topics which could be assigned as the headlines of the present days’ newspapers. By which the updates or the approx. evaluation of upcoming medicines would be clarified to the customers or to the normal general people of the society. So, there are a number of headlines that could add extra spices to the newspaper forum through the lines and paragraphs of it. Thus, the updates and the other topics regarding the Pharmaceutical industry reach up to the door to door of the citizens.
Here we are going to discuss upon those headline topics regarding the Pharmaceutical Industry News:
COVID-19 tracker: On the 4th of September at five military spots, AZ will test its shot. Merck might be pushed the two trial vaccines into the human body during this year alongside J&J is hopeful about their animal vaccination trial.
The ban on California Rat Poion: On Sept 4, 2020, at 9:26 AM it is declared from California that the bill would rethink the rat killing process which might cover the local wildlife with quite dire effectiveness.
Patient Assistance Program: On Aug 17th, 2020 it is conquered that Biopharmaceutical companies must invest strategically for patient assistance programs on the basis of believable and good partners’ presentation.
Biotech CEOs on COVID 19 trials and data releases: On 3rd Sept 2020 CEOs on the front lines of every Pharma companies working on the COVID 19 vaccine come in front of the headlines and declare that the day is not so far. The paperwork with the FDA is on the process. They included that their research would provide the world with a fruitful result. The biotech team has done a great job behind the creation and modulation of this massive vaccine manufacturing process.
Injecting Steroids are giving good results against COVID-19: On Sept 3rd, 2020, JAMA said that Findings from a series of clinical trials it is concluded that in some certain cases injection of steroids may be very much fruitful to bring up the patients out of the danger zone of COVID-19.
Fierce Pharma and Ora meeting: On Aug 10th, 2020, Hecht held a sitting down with Fierce Pharma to discuss the topic of how Ora supports their customers with good services and provides their best with their site managers.
Pfizer is going to publish the COVID vaccine results on next month: On Sept 3rd, 2020, Pfizer CEO Albert Bourla includes that their company would be going to publish the COVID Vaccine in front of this world next month. According to his speech, the work is already working on FDA authorization paperwork.
