Software Listing of Author : "Quality And Invention"

Good manufacturing practice (GMP) is the key part of the quality assurance for medicines in the European Economic Area (EEA). EU-GMP is to ensure that products are consistently produced and controlled to the quality standards appropriate to their intended use in EEA. Volume 4 in Eudralex (EU Legislation) for "The rules governing medicinal products in the European Union" contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively.

The EU-GMP Chapter App presents Part I (Chapter 1-9) and Part II of Volume 4 in Eudralex with user-friendly e-format. The users can easily reach to each part of the content. This is a convenient...

  • Platform: Android 2.x, Android 3.x, Android 4.4, Android 4.x

Good manufacturing practice (GMP) is the key part of the quality assurance for medicines in the European Economic Area (EEA). EU-GMP is to ensure that products are consistently produced and controlled to the quality standards appropriate to their intended use in EEA. The European Medicines Agency (EMA) plays an important role in coordinating GMP activities in collaboration with Member States. The EU-GMP principles and guidelines for medicines and investigational medicines for human use are stated in Directive 2003/94/EC.

The EU-GMP Guide App presents Directive 2003/94/EC (EU-GMP) in a user-friendly e-format. The users can easily reach to each section of the Directive. This is a convenient self-education and reference for all people working in pharmaceutical and biotech industries.

Keywords : Directive 2003/94/EC, EU-GMP, Good...

  • Platform: Android 2.x, Android 3.x, Android 4.4, Android 4.x

The various acts enforced by FDA require an adequate showing of product safety prior to introduction into the marketplace. In order to ensure adequate quality control for these studies and to provide an adequate degree of consumer protection, FDA promulgated the Good Laboratory Practice (GLP) regulations (21 CFR Part 58) in 1978. The regulations specify minimum standards for the proper conduct of safety testing and contain sections on facilities, personnel, equipment, standard operating procedures, test and control articles, quality assurance, protocol and conduct of a safety study, records and reports, and laboratory disqualification.
The GLP Booklet App presents the regulations for Good Laboratory Practice in a user-friendly e-format. The users can easily reach to each section of regulations with customized view options. This is a...

  • Platform: Android 2.x, Android 3.x, Android 4.4, Android 4.x

In US, current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. The Investigational New Drug (IND) and New Drug Application (NDA) applications are the vehicles through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the US. 21 CFR Part 312 and 314 contain regulations applied to conducting clinical trials, working with FDA, applying for drug approval and other related topics.

The IND/NDA booklet App presents the regulations for IND and NDA in a user-friendly e-format. The users can easily reach to each section of regulations with customized view options. This is a convenient information and reference tool for all people working in pharmaceutical and biotech industry.

Keywords :...

  • Platform: Android 2.x, Android 3.x, Android 4.4, Android 4.x

Molar Calculator is a user-friendly, simple, versatile App for calculating molecular weight and more. It contains a molecular weight calculator preset with the precise weights of 90 elements, including commonly used metallic elements in chemistry, for example, Silver (Ag), Tin (Sn), Palldim (Pd), Tunngsten (W), etc.. Without using the text based input, the user can profoundly differentiate similar chemicals, such like Carbon Disulfide (CS2) and Cesium (Cs), in the application.

More functions embedded in this App are a composition calculator, a molar number calculator and a set of calculators for concentration related calculations. The user can utilize the molar number calculator and the calculators for concentration related calculations, by using the molecular weight inherent from the molecular weight calculator or input the...

  • Platform: Android 2.x, Android 3.x, Android 4.4, Android 4.x

Premarket Approval (PMA) is the most stringent type of device marketing application required by FDA. PMA regulates most Class III medical device. A PMA is an application submitted for approval to market. PMA approval is to be based on a determination by FDA that the PMA contains sufficient valid scientific evidence that ensures medical device safety and efficacy. A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA).
Regulation also provides for the submission of a humanitarian device exemption (HDE) application. A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that...

  • Platform: Android 2.x, Android 3.x, Android 4.4, Android 4.x
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