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    About the author
    This article talks about the effective regulatory strategies for Medical Devices registration across the globe.
    Articles written by this author

    (Published: Thu, 06 May 2021 08:01:56 +0000)
    What is Structured Product Labeling SPL?, HL7, FDA, Regulatory submissions
    Structured Product Labeling (SPL) is a standard document approved and issued by Health Level Seven (HL7) to exchange information related to product and facility. It is used as a base for Regulatory guidance document in exchange for product labeling content. SPL ensures control over critical product
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:03:33 +0000)
    What is Biologics License Application?, BLA, Biologics, US FDA
    A Biologics License Application (BLA) is submitted to the Food and Drug Administration (FDA) to obtain permission for distribution of a biologic product across the states. It is regulated under 21 CFR 600-680. A BLA can be submitted by an applicant who is responsible for the safety and efficacy of t
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:05:49 +0000)
    Investigational Medical Product Dossier, IMPD Dossier, Europe
    The Investigational Medicinal Product Dossier (IMPD) is a document containing information about an investigational medicinal product (IMP) to be marketed in the EU. It includes various summaries of information related to the quality, manufacture and control of an IMP (including reference product and
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:07:13 +0000)
    What is Drug Master File? DMF Submissions, FDA, IND, NDA, ANDA
    A Drug Master File (DMF) is a type of submission made to the Food and Drug Administration (FDA) to provide important information related to facilities, processes or ingredients used for manufacturing, packaging or storing of any human drugs. Though it is not mandatory to file a DMF, the submission i
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:08:28 +0000)
    What is Integrated Summary of Safety, Integrated Summary of Efficacy, Regulatory Documents, ISS, ISE
    Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) are Regulatory submission documents which are required to be submitted to the Food and Drugs Administration (FDA) while filing a New Drug Application (NDA). The purpose of these documents is to report the outcomes of one or
    Directory: Technology
    (Published: Thu, 06 May 2021 08:09:33 +0000)
    What is 505b1& 505b2? NDA, NCE, USFDA
    The 505(b)(1) is a USFDA (United States Food and Drug Administration) Regulatory pathway traditionally known as New Drug Application (NDA). The Regulatory pathway is used to obtain approval for new drugs with previously unapproved active ingredients. These type of submissions require extensive resea
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:10:40 +0000)
    What is 351 A and 351 K? BLA, FDA, biological products, PHS
    351(a) is the traditional pathway for approval of biologics and innovator biologics under the Public Health Service (PHS) act. Under section 351(a), the submitted application must contain all the information regarding the safety and effectiveness of a biological product. It is also known as a “sta
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:14:19 +0000)
    What is Pharmacovigilance System Master File? PSMF, MAH, Europe
    A Pharmacovigilance System Master File (PSMF) is a comprehensive document containing the detailed description of a Marketing Authorization Holders’ (MAH’s) pharmacovigilance (PV) system ensuring the safety of their products. An MAH, who holds market authorizations (MAs) for one or more medicinal
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:15:50 +0000)
    What is a gxp? GMP, GCP, GLP, FDA, Regulations, Guidelines
    GxP is a set of regulations and quality guidelines formulated to ensure the safety of life sciences products while maintaining the quality of processes throughout every stage of manufacturing, control, storage, and distribution. The GxP standards were established by the Food and Drug Administration
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:16:47 +0000)
    What is A Private Label, Private label distributors PLD
    When a product is manufactured by one company but sold and distributed under the brand name of another company, it is known as a private label product. Private labels are a response to the challenges faced by manufacturers such as lack of resources, monetary deficit or heavy workload. Alternatively,
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:18:28 +0000)
    What is Regulated Product Submission RPS?, HL7 Standard, FDA, PDUFA
    Regulated Product Submission (RPS) is a Health Level Seven (HL7) standard designed to help the processing and review of regulated product information. Initiated on June 22nd, 2005, RPS is created for the registration of pharmaceutical products for human use. The purpose of RPS is to meet the goals s
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:32:43 +0000)
    What is Periodic Safety Update Report PSUR?, EMA, Europe
    A Periodic Safety Update Report (PSUR) is a pharmacovigilance document which provides information related to the risk-benefit balance of a drug product post its authorization. The purpose of a PSUR is to give an overall analysis of the risk-benefits of the product, considering all the information (i
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:33:48 +0000)
    What is eCTD? electronic Common Technical Document, eCTD submissions
    eCTD (electronic Common Technical Document) is a standard format of submitting Regulatory information (such as applications, supplements, and reports) to the concerned Health Authorities (HAs). It provides a harmonized solution to implement the Common Technical Document (CTD) electronically. An eCTD
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:34:54 +0000)
    What is Identification of Medicinal Products IDMP?, IDMP standards, medicinal products
    To harmonize specifications for identification and description of medicinal products internationally, a set of five EN/ISO international standards have been introduced. Identification of Medicinal Products (IDMP) provides base standards for identifying medicinal products uniquely to ensure smooth fu
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:36:01 +0000)
    What is new chemical entity NCE? Pharmaceuticals, USFDA
    A New Chemical Entity (NCE) is a drug that does not contain any active moiety that has been approved by the United States Food and Drug Administration (USFDA) with any other application. The manufacturers of an innovator drug generally develop a NCE during the early development stage of the product
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:37:01 +0000)
    What are Quasi Drugs? Beauty Products, South Korea, MFDS
    Quasi Drugs are one of the two primary categories of beauty products in South Korea. The other category of beauty products is cosmetics. There is a thin line between drugs and cosmetics, which can be considered as quasi-drugs. Since their benefits are not as suitable as drugs; South Korea’s health
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:38:10 +0000)
    What are purple and orange books? biological products, Generic Drugs, USFDA
    It is obvious that a bio-pharma product manufacturer would always first look for the existence of any similar product in the market. If it is to deal from the Regulatory perspective, the concern would be to chalk out their developmental/promotional strategies error-free. To enable all the generic dr
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:39:30 +0000)
    What Is A DUNS Number? Data Universal Numbering System DUNS, US FDA
    The Data Universal Numbering System, also known as DUNS number is a nine-digit unique identifier for businesses across the world. The DUNS number was created by Dun & Bradstreet (D&B), originally known as Mercantile Agency, in the year 1962 and is one of the oldest companies in the US. To obtain a D
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:50:54 +0000)
    What is PADER? Periodic Adverse Drug Experience Report, US FDA
    Periodic Adverse Drug Experience Report (PADER/PAER) is a part of post-cumulative safety reports which need to be submitted to the United States Food and Drug Administration (USFDA). The main purpose of a PADER is to update and evaluate a medicine’s global data and provide information about drug s
    Directory: Technology
    (Published: Thu, 06 May 2021 08:51:52 +0000)
    What is DHF? Design History File, medical device, USFDA
    Design History File (DHF) is a compilation of records that describes the design history of a finished device. The Design History File (DHF) was first mandated by the United States FDA in 1990 as part of the safe medical devices act; it contains all the product development documentation pertaining to
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:53:05 +0000)
    What is Product Information File PIF, CPSR, cosmetic products, Europe
    A Product Information File (PIF) is one of the most important legal requirements for placing a product in the market. Each cosmetic product is required to have a PIF of its own containing information about the product such as CPSR (Cosmetic Product Safety Report), product description, methods of man
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:54:42 +0000)
    What is Active Substance Master File, Certificate of Suitability, ASMF, EDMF, CEP
    An Active Substance Master File (ASMF), or formerly known as European Drug Master File (EDMF) procedure, is a set of documents that protects the valuable confidential intellectual property of the manufacturer. The purpose of an ASMF is to provide the Health Authorities (HAs) with complete informatio
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:55:38 +0000)
    what is individual case safety report?, ICSR, pharmacovigilance PV
    An Individual Case Study Report (ICSR) is a safety service document which includes information required for reporting the adverse events and problems related to products and complaints filed by consumers with respect to any product. It is an important facet of adverse event reporting which is a sour
    Directory: Advertising
    (Published: Thu, 06 May 2021 08:58:45 +0000)
    What is SmPC? summary of product characteristics, Pharmaceutical, EMA
    SmPC or Summary of Product Characteristics is a legal document which is a part of the marketing authorization of every medicine. The document acts as a basis of information on the use of medicines for healthcare professionals. The information included in the SmPC is updated regularly as per the emer
    Directory: Advertising
    (Published: Fri, 21 May 2021 09:20:19 +0000)
    Introducing or importing Chemicals in Australia
    This article talks about the steps that must be followed by chemicals manufacturers to introduce/import their products in Australia to align with AICIS regulations.
    Directory: Health
    (Published: Thu, 17 Jun 2021 13:11:59 +0000)
    What are purple and orange books? biological products, Generic Drugs, USFDA
    Purple book is a list of innovator biological products, including biosimilars and interchangeable biological products licensed by FDA under the PHS Act and the Orange book is a list of generic drugs approved by FDA
    Directory: Health
    (Published: Thu, 17 Jun 2021 13:13:22 +0000)
    What is Corrective Action and Preventive Action, CAPA FDA
    Corrective Action Preventive Action (CAPA) is an approach used to investigate and resolve quality issues along with identifying their causes. It was introduced as a result of Food and Drug Administration’s (FDA) requirement under FDA 21 CFR 820.100. The CAPA mainly consists of two functions: Co
    Directory: Health
    (Published: Thu, 17 Jun 2021 13:14:27 +0000)
    What is FDA Unified Registration and Listing System, FDA FURLS, FDA Registration and Listing
    FURLS is a Food and Drug Administration’s (FDA) Unified Registration and Listing System. It is used by the FDA to help applicants register through the online system and make electronic submissions. FURLS is also used by other centers within the FDA as a system for registration and listing. FURLS a
    Directory: Health
    (Published: Thu, 17 Jun 2021 13:15:28 +0000)
    What is Post-Authorisation Safety Study, PASS, Imposed PASS, Voluntary PASS
    The post-authorization safety study (PASS) is a study conducted after a medicine has been authorized, to draw more information related to the safety of the medicine or to ensure the effectiveness of measures of risk management. The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessmen
    Directory: Health
    (Published: Thu, 17 Jun 2021 13:16:47 +0000)
    What is TPD? therapeutic product directorate, Health Canada
    The Therapeutic Product Directorate (TPD) is Canada’s federal authority responsible for regulations of prescription drugs for human use. In order to sell a prescription drug in Canada, scientific evidence for the product must be obtained from the directorate, as per the Food and Drug Regulations.
    Directory: Advertising
    (Published: Thu, 17 Jun 2021 13:43:09 +0000)
    What is office of generic drugs OGD? USFDA, generic drugs, CDER
    The Food and Drugs Administration’s Office of Generic Drugs (OGD) is a division under the Center for Drug Evaluation in Research (CDER) that focuses on the approval and facilitation of generic drugs. The purpose of the OGD is to ensure that the drug products distributed in the United States (US) a
    Directory: Health
    (Published: Thu, 17 Jun 2021 13:45:56 +0000)
    What is Australian Public Assessment Report AusPAR? TGA, Australia
    The Australian Public Assessment Report (AusPAR) is an assessment report provided by the Therapeutic Goods Administration (TGA) to demonstrate the transparency of registration process of the prescription medicines. The purpose of the report is to provide information about the pre-registration proces
    Directory: Health
    (Published: Thu, 17 Jun 2021 13:47:25 +0000)
    What is CE marking? Medical devices, Europe, CE certification, CE marking
    To sell a medical device in the European Union (EU), it is mandatory for manufacturers to obtain or apply for CE marking for the product. CE marking ensures that the medical device is compliant with the EU regulations and can be distributed in all the 32 European countries of the region. It is the r
    Directory: Health
    (Published: Thu, 17 Jun 2021 13:48:44 +0000)
    Mexican Registration Holder, MRH, Medical devices licensing, COFEPRIS
    Mexico is possibly one of the most lucrative markets in Latin America, particularly for exporting medical devices. According to local legislation, any foreign manufacturer who wants to launch their products in Mexico should have a local office or must appoint a Mexican Registration Holder (MRH) for
    Directory: Health
    (Published: Thu, 17 Jun 2021 13:50:25 +0000)
    eCOSMA Notification Process, Cosmetic Products Registration, SFDA
    Most of the cosmetic products in Saudi Arabia are imported, making it a lucrative market for the cosmetic industry. However, before a company can begin to market and sell their products in the Kingdom of Saudi Arabia, they must notify and register each product with the local health authority, Saudi
    Directory: Health
    (Published: Thu, 15 Jul 2021 11:09:10 +0000)
    EU CLP regulations on labeling and packaging requirements
    This article talks about the EU CLP regulations on labeling and packaging requirements for hazardous chemical substances/Mixtures.
    Directory: Health
    (Published: Thu, 15 Jul 2021 11:35:13 +0000)
    EU MDR Compliance & Key Requirements
    This article talks about the EU MDR Key Requirements for medical device manufacturers to be compliant.
    Directory: Health
    (Published: Wed, 21 Jul 2021 06:26:46 +0000)
    Food and Dietary Supplements Regulatory Pathways in Australia and New Zealand
    This article talks about the Food and Dietary Supplements Regulatory Pathways in Australia and New Zealand Markets.
    Directory: Health
    (Published: Wed, 21 Jul 2021 06:28:41 +0000)
    US EPA Regulations for registration of Disinfectants in USA
    This article talks about the US EPA regulations for disinfectant manufacturers to register their products in USA.
    Directory: Health
    (Published: Wed, 21 Jul 2021 06:48:36 +0000)
    Effective Regulatory Strategies for Medical Devices Registration Across the Globe
    This article talks about the effective regulatory strategies for Medical Devices registration across the globe.
    Directory: Health

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