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SANITIZER

CATEGORY : Allopathy


SUB CATEGORY : Lotions


SUB SUB CATEGORY : Aromatic Waters


STRENGTH : 70%


PHARMACOPOEIAL STATUS : -


LABEL CLAIM : -


MARKET : Global


Displayed By :

ACME PHARMACEUTICALS



Price : ₹0.00 /
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  • General Avaliable
    Application form (Hard copy and electronic format) Avaliable
    Mfg.lic, -notary copies Avaliable
    FSC & COPP- notary copies Not Avaliable
    WHO GMP- notary copies Not Avaliable
    Special Export Permission (If Applicable) Avaliable
    Summary of product characteristics, labeling and package leaflet/insert-English Avaliable
    Summary of product characteristics Avaliable
    Labeling Avaliable
    Package leaflet/insert -(Country specific language) Avaliable
    Mockups and samples of trade packages (if samples of trade packages are not available – a sample in final immediate (inside) package without final labeling shall be submitted. In this case a sample in final immediate (inside) and secondary (outer) packages should be given additionally as soon as it is available. Further on, for approval of methods of quality control of the medicinal product additional samples, reference substances with batch certificate including date of production, shelf life and storage conditions could be requested. - Country Specific Language Avaliable
    Summary of product characteristics approved in manufacturer/applicant country.    (specification of origin of the country) Avaliable
    Environmental risk assessment including Standards of the manufacturing facility and effluents treatment details to be mentioned Avaliable
  • Table of contents of module-2, module-3, module-4 and module-5 Avaliable
    Introduction to CTD Avaliable
    General summary on quality Avaliable
    DRUG SUBSTANCE (NAME, MANUFACTURER) Avaliable
    General Information Avaliable
    Manufacture Avaliable
    Characterization Avaliable
    Control of Drug Substance Avaliable
    Reference Standards or Materials Avaliable
    Container Closure System Avaliable
    Stability Avaliable
    DRUG PRODUCT (NAME, DOSAGE FORM) Avaliable
    Description and Composition of the Drug Product Avaliable
    Pharmaceutical Development Avaliable
    Manufacture Avaliable
    Control of Excipients Avaliable
    Control of Drug Product Avaliable
    Reference Standards or Materials Avaliable
    Container Closure System Avaliable
    Stability (As per country requirement) Avaliable
    Review of preclinical data Avaliable
    Review of clinical data Avaliable
    Summary of pre-clinical data Avaliable
    Introduction Avaliable
    Summary of pharmacological data in text format Avaliable
    Brief Summary Avaliable
    Primary Pharmacodynamics Avaliable
    Secondary Pharmacodynamics Avaliable
    Safety Pharmacology Avaliable
    Pharmacodynamic Drug Interactions Avaliable
    Discussion and Conclusions Avaliable
    Tables and Figures Avaliable
    Summary of pharmacological data in tabular format Avaliable
    Summary of pharmacokinetics data in text format Avaliable
    Methods of Analysis Avaliable
    Absorption Avaliable
    Distribution Avaliable
    Metabolism (interspecies comparison) Avaliable
    Summary of pharmacokinetics data in tabular format Avaliable
    Summary of toxicological data in text format Avaliable
    Summary of toxicological data in tabular format Avaliable
    Summary of clinical data Avaliable
    Summary of biopharmaceutical studies and related analytical methods Avaliable
    Summary of clinical pharmacology studies Avaliable
    Summary of clinical efficacy Avaliable
    Summary of clinical safety Avaliable
    Copies of used literature sources Avaliable
    Short reviews of individual trials Avaliable
  • Table of contents Avaliable
    Relevant data Avaliable
    Medicinal substance (for medicinal products containing more than one medicinal substance an information should be given in full with respect to each of them) Avaliable
    General information Avaliable
    Name Avaliable
    Structure Avaliable
    General properties Avaliable
    Manufacturer Avaliable
    Manufacturer Avaliable
    Description of manufacturing process and its control Avaliable
    Control of materials Avaliable
    Control of critical stages and intermediate products Avaliable
    Process validation and/or its assessment Avaliable
    Development of manufacturing process Avaliable
    Characteristics Avaliable
    Demonstration of structure and other characteristics Avaliable
    Impurities Avaliable
    Control of medicinal substance Avaliable
    Specification Avaliable
    Analytical methods Avaliable
    Validation of analytical methods Avaliable
    Batch analysis 3 BATCH COA (VALIDITY) Avaliable
    Substantiation of specification Avaliable
    Standard samples or substances 1BATCH COA (VALIDITY) Avaliable
    Container/closure system Avaliable
    Stability (As per country requirement) Avaliable
    Summary on stability and conclusions Avaliable
    Report on post-registration stability study and stability associated obligations Avaliable
    Stability data Avaliable
    Medicinal product Avaliable
    Description and composition of the medicinal product Avaliable
    Development pharmaceutics Avaliable
    Constituents of the medicinal product Avaliable
    Medicinal substance Avaliable
    Excipients Avaliable
    Medicinal product Avaliable
    Development of composition Avaliable
    Overages Avaliable
    Physical and chemical, and biological properties Avaliable
    Development of manufacturing process Avaliable
    Container/closure system Avaliable
    Microbiological characteristics Avaliable
    Compatibility Avaliable
    Manufacture Avaliable
    Manufacturers Avaliable
    Composition for batch Avaliable
    Description of manufacturing process and process control Avaliable
    Control of critical stages and intermediate products Avaliable
    Process validation and/or its assessment Avaliable
    Control of excipients Avaliable
    Specifications Avaliable
    Analytical methods Avaliable
    Validation of analytical methods Avaliable
    Justification of specifications Avaliable
    Excipients of human and animal origin Avaliable
    New excipients Avaliable
    Control of medicinal product Avaliable
    Specification (-s) Avaliable
    Analytical methods Avaliable
    Validation of analytical methods Avaliable
    Batch analysis Avaliable
    Characteristics of impurities Avaliable
    Substantiation of specification (-s) Avaliable
    Standard samples and substances Avaliable
    Container/closure system Avaliable
    Stability Data
    Summary and conclusions on stability studies Avaliable
    Report on post-registration stability study and stability associated obligations Avaliable
    Stability data Avaliable
    Amendments Avaliable
    Technical devices and facilities Avaliable
    Safety assessment of foreign microorganisms Avaliable
    New excipients Avaliable
    Regional  information Avaliable
    Copies of used literature sources Avaliable
  • Table of contents Avaliable
    Pharmacology Avaliable
    Primary pharmacodynamics Avaliable
    Secondary pharmacodynamics Avaliable
    Safety pharmacology Avaliable
    Pharmacodynamic drug interactions Avaliable
    Pharmacokinetics Avaliable
    Analytical methods and their validation report Avaliable
    Absorption Avaliable
    Distribution Avaliable
    Metabolism Avaliable
    Excretion Avaliable
    Pharmacokinetic drug interactions (pre-clinical) Avaliable
    Other pharmacokinetic studies Avaliable
    Toxicology Avaliable
    Toxicity after a single dose administration Avaliable
    Toxicity after repeated administration Avaliable
    Genotoxicity Avaliable
    Carcinogenicity Avaliable
    Reproductive and ontogenetic toxicity Avaliable
    Local tolerance Avaliable
    Other toxicity studies Avaliable
    Copies of used literature sources Avaliable
  • Table of contents Avaliable
    List of all clinical trials in tables Avaliable
    Report of clinical trials Avaliable
    Reports on biopharmaceutical studies Avaliable
    Reports on studies related to pharmacokinetics studies with use of human biomaterials Avaliable
    Reports on pharmacokinetic studies in human beings Avaliable
    Reports on pharmacokinetic studies in human beings Avaliable
    Reports on efficacy and safety studies Avaliable
    Reports on post-registration experience Avaliable
    Samples of individual registration forms and individual lists of patients Avaliable
    Copies of used literature sources
    Joint analysis and Registration
    Availability of Any Other Details : (COUNTRY SPECIFIC requirements - Except above mentioned)

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