background preloader


Facebook Twitter


Biotechresearchgroup: Know about regulatory affairs services in the pharmacy sector. The essence of regulatory affairs services in the pharmacy are to help find the path that differentiates it as a company and once found, walk that path together to help in all eventualities that may arise along with it.

Biotechresearchgroup: Know about regulatory affairs services in the pharmacy sector

Identify opportunities that allow the pharmacy, without losing the essence with which they were born and trusted by customers, optimize results, reduce costs and increase revenues are some of the benefits we can get from having a consultant by our side. A large number of biologics development services today decide for various reasons, which need to go much further and quickly. The Self-Care Solution: Rx-to-OTC Switch. The United States and many European countries are witnessing a trend in medicinewhere people are administering self-care.

The Self-Care Solution: Rx-to-OTC Switch

The self-care trend may be due to many factors including high costs in medical care, busy schedules, and the need to get treated immediately. Many pharmaceutical companies are taking advantage of this trend by converting prescription drugs to over-the-counter, which is known as Rx-to-OTC Switch. Toxicology Studies in Drug Development - BRG. The FDA regulates all investigational new drug applications and requires drug developers to adhere to the regulatory procedure for the development of new drugs.

Toxicology Studies in Drug Development - BRG

The drug development process is comprised of non-clinical and clinical studies using different protocols, which mostly follow the Good Laboratory Practice (GLP). Toxicity studies address the issue of the drug’s safety to the consumer. The drug sponsor will be assigned an FDA review team. One member of this team will bea pharmacology/ toxicology reviewer and he or she will be responsible for reviewing the results of these tests.

The drug must undergo numerous toxicology studies includingreproductive toxicity studies, genotoxicity, and carcinogenicity studies. Reproductive Toxicology Studies. Quality Control vs Quality Assurance (Quality consulting) Quality is key to any successful business.

Quality Control vs Quality Assurance (Quality consulting)

Quality ensures standards are being met in processes or products. Companies involved in pharmaceuticals, biologics, medical devices, or other scientific-based organizations should have a Quality Assurance Program or Quality Management Program, especially due to regulatory compliance. Contained in this program are two components that are important to its success- quality control and quality assurance. It is common for individuals to use quality control and quality assurance interchangeably. While both are vital to a quality assurance program, they are both quite different. Quality assurance is a set of systematic activities implemented within the quality system that can be demonstrated to provide confidence that a product or service will fulfill requirements for quality. Quality control identifies when quality standards are not met in processes or products. Biotechresearchgroup: We Are Consulting About the Control Process for The Medical Design.

The biologics business is heavily regulated with FDA’s dynamical landscape of regulative elements.

Biotechresearchgroup: We Are Consulting About the Control Process for The Medical Design

Learn About NDA Pre-Submission Activities - BRG. Hundreds of New Drug Applications (NDA) are submitted to the FDA every year.

Learn About NDA Pre-Submission Activities - BRG

The NDA has served as a vehicle to the road of marketing a new drug in the United States. Pharmaceutical companies have relied on NDA consultants for their expertise and to receive NDA regulatory services. Prior to submitting an NDA, applicants must perform pre-submission activities, such as proprietary submission and review, establishment registration and labeler code assignment, and a pre-submission meeting request.

Common Reasons for IND Clinical Holds - BRG. After sponsors and their Pre-IND consulting firm have built a great foundation, they will be ready to file an Investigation New Drug (IND) application.

Common Reasons for IND Clinical Holds - BRG

IND applicants hope to pursue their clinical studies without any hiccups. Sponsors submitting IND applications undergo a thirty-day review. The IND does not get approved by the FDA, instead it becomes effective thirty days after the FDA acknowledges receipt of the application. If the FDA finds deficiencies, the sponsor can correct them within the thirty-day review period without delaying the effective date. The FDA utilizes clinical holds to delay proposed clinical investigations or to suspend active investigations. Legal Support for Qualifying Cases with Best Medical Expert WitnessBiotech Research Group. Biotech Research Group (BRG) provides litigation support and research, as well as expert testimony, to the legal community for qualifying cases.

Legal Support for Qualifying Cases with Best Medical Expert WitnessBiotech Research Group

Our commitment to data-driven analyses forms the foundation for our selection of assignments. Our expert witness will work in partnership with your legal team members to ensure those involved in the litigation will have a thorough knowledge of the scientific and regulatory matters at issue. Our solid credibility and meticulous preparation have earned the trust of our clients for FDA interactions and submissions,and in the courtroom. BRG’s experience in pharmaceutical industry litigation includes participation in both civil and criminal cases on the state and federal level involving: failure to warn, product liability, product failure, contractual disputes, patent infringement, securities, anti-trust and class action-related cases.

BRG’s expertise in litigation support services includes, but is not limited to: Pharmaceutical Research CompaniesBiotech Research Group. Imagine the value of continuous access to the specialty pharmaceutical consulting services and resources necessary to complete tasks that are out of the ordinary, unexpected, or for which you just don’t have time.

Pharmaceutical Research CompaniesBiotech Research Group

Most of our clients do not have the resources to execute each facet of every project they must complete. Unexpected events such as product licensing opportunities or newly implemented FDA regulations may demand immediate attention and expertise. Service to our clients in situations just like these has taught us that successful companies are always positioned to address such challenges. Biotech Research Group is one of a few pharmaceutical consulting firms that provides a wide variety of drug consulting competencies through our specialty services that will help address any regulatory needs with immediacy and quality. Given our versatility, it should come as no surprise Biotech Research Group has completed a large number of diverse projects for our clients.

FDA and Regulatory Compliance – Quality Consulting. Hire Top FDA 510k Consultants For Medical Device ConsultingBiotech Research Group. Biotech Research Group has certified regulatory affairs professionals that have years of experience working with the FDA throughout the pharmaceutical, biologics, and medical device industries.

Hire Top FDA 510k Consultants For Medical Device ConsultingBiotech Research Group

Why hire one FDA 510k consultant when you can have a group of savvy FDA 510k consultants that will carefully consider all strategies and alternatives during each step of the regulatory process? Biotech Research Group has expertise with a wide range of medical devices across all classes. Medical devices are increasingly more challenging from a regulatory perspective. Expert NDA consultants for NDA application505(b)(2) with ANDA consultantsBiotech Research Group. Our pharmaceutical consulting group has expert ANDA Consultants, NDA Consultants and IND Consultants to provide the best support for our clients. Biotech Research Group’s FDA Consultants has in-depth knowledge on how to prepare all FDA drug submissions including: ANDA application (Abbreviated New Drug Application)NDA application 505 (b)(2) (New Drug Application)INDapplication (Investigational New Drug)DMF application (Drug Master File) Unlike other pharmaceutical consulting firms, our certified regulatory professionals have well over 50 years of combined experience building strong relationships with FDA agents.

Let our knowledgeable staff provide you with full-service for your submission or serve as a partner to guide you through the drugs FDA pathway. Hire BLA FDA Consulting group for Biologics Consulting USABiotech Research Group. Pharmacovigilance - Health Products Regulatory Affairs Services. How to avoid FDA 483 at NDA pre-approval inspection? Pre-approval inspection plays the most critical role in getting the commercial license for the new manufacturing platform or a new drug. In any instance, if you do not meet these standards during the NDA pre-approval inspection process, it will create lots of legal complexities and unexpected delay in the marketing of your products which cost you more money.

When it comes to FDA, it approves an NDA (New Drug Application) only if all procedures, methods, and facilities used at each step from the raw materials to drugs distribution are enough for preserving the quality, strength, identity, and purity of the drug. It is always helpful to know that are required for cleaning this pre-approval inspection. The PAI (pre-approval inspection) manager is a liaison between the parties. The manager actually reviews your GMP history and observation forms before scheduling your pre-approval inspections. Major requirements You are required to fully comply with the CGMPs. Know The Effective Process Of Pharmaceutical Consultants. Basically, the biotech research group is product development and full service regulatory consulting organization.

A professional company will have a consultant and clients worldwide with a large number of quantities. The expert pharmaceutical consultants will have the major aim to provide top notch and most efficient solution for the products of the clients which include medical devices, scientific services, pharmaceutical consulting, healthcare information technology and much more. Addition to that, the biotech research group experts will be knowledgeable and highly experienced biologics consulting group in their field. A standout amongst the most significant and basic pieces of Biotech consulting is the patent technique or in straightforward words, patent-based consultation to assess patent objectives with that of R and D.

Experts in worldwide: Quality work from consultants: Cost and time effective: Regulatory Administrative Action Letters - Biotech Research GroupBiotech Research Group. Human Cell, Tissue, and Cellular and Tissue-based Products (HCT/Ps) establishments are regulated under FDA’s Center of Biologics Evaluation & Research (CBER). HCT/Ps establishments are under strict scrutiny, where the distribution of potentially contaminated HCT/Ps are of great concern. If the FDA observes any critical violations of 21 CFR 1271, the FDA could issue a regulatory administrative action letter. Hire an FDA Consulting Service To Ensure All Medical Products Is Safer To Use. With great development in the field of medical device, there are number scientific researches our but not equal. Here the Biotech Research Group is applicable to open at 24 hours and our staffs work well to full fill need of the client.

We understand the necessity of having a question as well as the well collaborating time. Our group filled with a number of doctors, toxicologist, pathologist and another common public health professional in major countries and also it let to serve the world community. Major Impacts Involved In Framework Of A Validation Report - validation report. In general, the U.S. Role Of The FDA US Agents For A Complete Analysis – Michel Gally. Foreign establishments who normally imported the United States need to completely identify the FDA U.S. Agent for the whole registration process. Before discussing the FDA US Agent, it is important to know about the Establishment Registrations and Product Listings. In fact, it is not as same as tat of the FDA approvals but it is also required for numerous aspects. Utilize The Ultimate Process Of Medical Device Subsystem Consultants by biotechgroup. FDA Regulatory Advisory Action Letter - Biologics Consulting Group - Biotech Research Group.

Implementation of HFE Principles in Medical Device Design - Biotech Research GroupBiotech Research Group. Pharmaceutical Consulting Firms - FDA’s Expedited Pathways - Biotech Research GroupBiotech Research Group. Tips To Make You Ready For Your Dental Appointment. Maximum people before visiting a dentist do not care about considering the essential things. This can make things tough between you and your dentist. That is the reason why we are here to highlight the important tips that you can consider before making a dentist appointment in Dental Lounge Dubai. These are things which are very important from all aspects and you should add them in your mandatory list before you book an appoint with Dentist Karama. Hire The Best Biotech Research Group Of Medical Device Consulting - Medical Device. The Process Of Best Quality Medical Device Consulting Service -

Reporting Medical Device Consulting Adverse EventsBiotech Research Group. Errors associated with medical devices can be costly to health institutions and manufacturers, with some patients paying the ultimate price with their lives. Some of these medical device errors could be prevented. The U.S. Balancing FDA Compliance in a Pharmaceutical EnvironmentBiotech Research Group. Regulatory compliance is a significant topic among quality management personnel. In a pharmaceutical environment, failure to comply with FDA regulations can have serious consequences. The task of operating various departments such as processing, research and development, packaging, and distribution and ensuring that quality compliance is being achieved can be difficult.