Preservatives are used in cosmetic products to ensure their safety during their lifetime. As many cosmetics contain water, once exposed to the environment, they become prone to the growth of microorganisms. Furthermore, every time a consumer interacts with the product, it gets introduced to a new population of microorganisms directly from the air or skin.
- December 9, 2022 Cosmetics Regulatory Services, Regulatory Affairs
- December 9, 2022 Medical Devices, Regulatory Affairs
An organized system of protocols and practices known as a medical device quality management system (QMS) addresses all facets of design, production, supplier management, risk management, complaint handling, clinical data, storage, distribution, product labeling, and more.
- December 9, 2022 Pharmaceuticals, Regulatory Medical Writing
A comprehensive compilation of clinical and nonclinical data on the investigational product (drug, supplement, device, or other product) provides a brief description of the drug substance and the formulation, including the structural formula (if known).
- December 8, 2022 Medical and Scientific Communication, Pharmaceuticals, Regulatory Affairs
Marketing promotions and advertisements in Pharmaceuticals are information of nexus where research concepts are transformed into realistic therapeutic tools, and information is made useful for different sectors in the Health care system. Every year pharmaceutical companies spend a large part of their revenues on promotions and advertising for the successful launch of pharmaceutical products.
- December 6, 2022 Medical Devices, Regulatory Affairs
The importance of post-market surveillance (PMS) has never been out of the buzz. Regulatory Authorities worldwide have established some stringent rules and regulations to efficiently monitor medical devices even after placing them on the market. Similarly, the European Union (EU) has emphasized PMS in its new regulations.
- December 6, 2022 Medical Devices, Regulatory Affairs
The Pharmaceuticals and Medical Devices Agency (PMDA) releases Medical Device Safety Communications (MDSCs) to convey important safety information to patients and healthcare professionals. PMDA releases different types of safety communications, such as:
- November 30, 2022 Medical Devices, Regulatory Affairs
In a global marketplace with more than 7,100 spoken languages, manufacturers need to consider the local language and culture when developing medical device product labels. How does one make it possible to reach out to a diverse group of people?
- November 29, 2022 Pharmacovigilance, Pharmaceuticals, Regulatory Affairs
Marketing Authorization Holders (MAHs) with medicinal products authorized for marketing in the European Economic Area (EEA) have a legal responsibility of establishing a PV system for accomplishing PV obligations for their products. To this end, the MAHs in the European Union (EU) must appoint an appropriately qualified person for PV (QPPV). The role and responsibilities of the QPPV include, but are not limited to:
- November 29, 2022 Regulatory Affairs, Publishing & Submissions, Regulatory Software & Services
Since 2003, eCTD has been accepted by several Health Authorities around the world. Its standard has evolved incrementally over time. Based on the Health Level Seven (HL7) standard called RPS (Regulated Product Submission), eCTD 4.0 brings in major changes and introduces certain substantial updates.
- November 29, 2022 Regulatory Labeling, Health Authority Updates
In July 2022, the United States Food and Drug Administration (US FDA) issued draft guidance titled ‘Human Prescription Drug and Biological Products - Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers - “Dose Banding.” It is to help sponsors include dose banding information in drug labeling for ready-to-use containers…