What is localization and why you need it?

Are you exploring finding effective ways to approach your target customer? Are you considering a localization service? Are you planing to enter South Korea market? Do you have a special differentiation strategy? Do you want to reassure your overseas customers? The answer to all these questions is providing a proper localization service. A key factor of the localization is talking the same language with your customers. You can make good friends with your customers, if you find what they eat, drink, prefer or seek and what are they struggling with thesedays. Find and choose your right localization provider or transcreator. If you want to find a right localization provider for Korean market, pl

CGMP Regulations

FDA ensures the quality of drug products by carefully monitoring drug manufacturers' compliance with its Current Good Manufacturing Practice (CGMP) regulations. The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have. The approval process for new and generic drug marketing applications includes a review of the manufacturer's compliance with the CGMPs. FDA assessors and inspectors determine whether the firm has the necessary facilities, equipment, and ability t

Clinical Trial Protocol

https://clinicaltrials.gov/ProvidedDocs/85/NCT01619085/Prot_000.pdf https://clinicaltrials.gov/ProvidedDocs/52/NCT03235752/Prot_000.pdf Example #2 provided as a guide, customize as needed: Flow diagram https://osp.od.nih.gov/wp-content/uploads/2014/01/Protocol_Template_05Feb2016_508.pdf Clinical Study Protocol Variability of Parkinson’s Disease Biomarker Analytes http://www.ppmi-info.org/wp-content/uploads/2011/09/Verification-study-in-control-subjects-protocol.pdf Clinical Trials Protocol Templates Applicants conducting phase 2 or 3 clinical trials that require Investigational New Drug applications (IND) or Investigational Device Exemption (IDE) applications can use a NIH-FDA template with

What is GMP?

Good Manufacturing Practice (GMP) Resources Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the

What is SOP?

Standard operating procedure A standard operating procedure (SOP) is a set of step-by-step instructions compiled by an organization to help workers carry out complex routine operations. SOPs aim to achieve efficiency, quality output and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations. The military (e.g. in the U.S. and UK) sometimes uses the term standing (rather than standard) operating procedure because a military SOP refers to a unit's unique procedures, which are not necessarily standard to another unit. The word "standard" can imply that only one (standard) procedure is to be used across all units. https://en.wikipedia.org/wiki/

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