March 3, 2022
In brief All biomaterials and medical devices must comply with various Pharmaceutical Regulatory standards and rules to receive clearance. It covers a range of processes and […]
March 2, 2022
In brief Manufacturers perform post-market surveillance to gather and assess experience obtained from medical devices that have been placed on the market and determine the need […]
March 1, 2022
In brief Regardless of industry, decisions should be founded on facts. The significance of data collecting and analysis based on it The more precise the information […]
February 28, 2022
In brief Literature searching is generally accepted as an essential part of the literature review process. It entails a study search in the literature to produce […]
February 26, 2021
In-Brief Biosimilars signify a new class of medical products that will significantly impact the clinical practice of pharmacovigilance literature search. They are the same on an […]
February 23, 2021
In-Brief: Clinical Trial Management Systems (CTMS) are an essential part of every clinical trial. Choosing the right CTMS helps address inadequacies on the operational side of […]
February 18, 2021
In-Brief: Effective planning is fundamental to success for any business but an even greater degree in the medical device manufacturing industry. Pepgra covers the top 5 […]
February 17, 2021
In-Brief: Fronting ever-increasing costs of running a clinical trial, sponsors must guarantee they are correctly directing their financial plan and resolving the highest risk areas while […]
February 11, 2021
In-Brief: E-labelling is not new evidence; nor is its use partial to the life sciences business. Creating the latest product data available online adds value across […]
February 9, 2021
In-Brief: Medical writers must be subject matter experts of the regulatory control inside and out and know the drug under study in clinical research. To prepare a […]
December 17, 2019
1.0 Background The implementation of the new medical device regulations (MDR) on 25th May, 2017 has presented medical device manufacturers with several drastic changes in the […]
January 10, 2020
1.0 Background Adverse drug reactions assume much significance in terms of risk associated with safety of patients and could make a major impact on costs related […]
February 4, 2020
In Brief This particular write-up presents a background about e-dossiers that are submitted to regional authorities by pharmaceutical companies for drug registrations. The write-up highlights the […]
February 11, 2020
In Brief Medicines and devices that are supposed to be launched are based on industry composition where above 80% small and medium-sized companies require medical devices […]
February 18, 2020
In Brief For long, medical device regulations continued to remain stagnant till such time that the world was struck with the hip replacement and breast implant […]
March 2, 2020
In Brief Different medical devices have different parameters through which it can be classified. With that reasoning, it does not make sense to subject all medical […]
March 3, 2020
In Brief The new European Union (EU) post-market surveillance (PMS) plan would act as a detailed tool for benefit-risk evaluation for medical devices. If the […]
April 19, 2020
Introduction PSURs are pharmacovigilance documents that provide risk-benefit balance assessment. The notion of PSUR is to offer a wide and complex evaluation of risk-benefit balance of […]