CTD (Common Technical Document) is a set of specification for application dossier. View Details Clinical Studies As a critical element of the product registration process, pharmaceutical dossiers are essential documents to be submitted at the Food and Drug Administration. ...
Stability testing on pharmaceutical products is carried out to demonstrate that product quality remains fit for purpose until the end of its shelf-life when stored as recommended, and during use by healthcare professionals or patients. International and regional guidelines on stability testing have ...
Furthermore the provisions of the general chapter 5.10 Control of impurities in substances for pharmaceutical use are to be taken into consideration. Possible impurities originating from the route of synthesis or from degradation should be listed and discussed with an indication of their origin (...
from product discovery to closed deal We assist you in discovering new products, matching with potential qualified manufacturers, and making the deals happen. 1. Discover new productsSearch for the high-potential products in the largest expert-curated CTD database. Narrow your search applying the in...
Content_of_the_dossier_for_chemical_purity_and_microbiological_quality-中英.pdf 关闭预览 想预览更多内容,点击免费在线预览全文 免费在线预览全文 Certification Unit CP/CB PUBLIC DOCUMENT (Level 1) (Level 1) PA/PH/ CEP (04) 1 4R February 2007 Certification of suitability of Monographs of the Euro...
Variations In addition to taking on the tasks related to the documentation for your dossier, Diapharm also offers support when it comes to the formal requirements imposed on pharmaceutical companies. On request, we will take direct responsibility for your product – for example, by taking over func...
dossierqosproductsummaryqualitymonograph MODULE2.3 QUALITYOVERALLSUMMARY–ProductDossier(QOS-PD) (2015-12-04) Seesections1.5,3and4of“Guidelineonsubmissionofdocumentationforamultisource(generic)finishedpharmaceuticalproduct(FPP):qualitypart”forgeneralanddetailedinstructionsonthecompletionofthistemplate. INTRODUCTION...
Product Description Company Info. Overview Product Description Detailed Photos Our Advantages Basic Info. Model NO. 20mg/2ml Suitable for Elderly, Adult State Liquid Shape Liquid Type Inorganic Chemicals Pharmaceutical Technology Chemical Synthesis Finished Medicines Gastrointestinal Transpo...
ACTD_OrganizationofDossier THE ASEAN COMMON TECHNICAL DOSSIER (ACTD) FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ORGANIZATION OF THE DOSSIER
A market approval is required for every overseas pharmaceutical enterprise to sell its product in China. However, preparing the registration dossier in accordance with format and content requirements of China CDE can be difficult and time-consuming. ACCESTRA will help you take the pressure off. Our...