Pharmaceutical Dossier is a collection of documents which provide detailed info about drugs to get licensed in Pharma.
Pharmaceutical Dossier- Pharma ACTD Dossiers. Non-ACTD & CTD/eCTD - Pharma. Non-ACTD & CTD/eCTD Dossier (Country Specific) PharmaActdDossiers service are offering dossier as Non-ACTD & CTD/eCTD Dossier services as per country specific guideline.
PharmaActdDossiers service offer a full report writing service. This service is offered where clients’ needs are closely matched to industry documentation conventions. Generation of all documentationStability reports compiled in accordance with CPMP-ICH preferred format which leads to ready incorporation into dossier submissionsCompilation stability testing protocols, validation protocols & Validation reportsPreparation of DCGI Files & COPP data.Dossier Preparation as per MOH requirement. We support till the receipt of Registration certificate. Formulation And Development. Pharmaactddossiers write dossiers that meet all regulatory requirements and is in accordance with all legal demands.
PharmaActdDossiers Service is a leading international services organization that helps customers to overcome the challenges within the rapidly evolving global pharmaceutical market. We are offering dossier as per European CTD / ASEAN CTD / non-CTD (country specific guideline). Pharmaactddossiers offers supportive services of medical writing to pharmaceutical companies as follows; Global Pharmaceutical Licensing. Profile Dossier, is a comprehensive consultancy service provider to the pharmaceutical and associated Industries.PharmaActdDossiers Service is a leading international services organization that helps customers to overcome the challenges within the rapidly evolving global pharmaceutical market.
PharmaActdDossiers Service prepare dossier as per European CTD / ASEAN CTD /non-CTD (country specific guideline) Administrative Documentation:- • Writing Registration Application & Covering Letter • Letter of Authorisation Drafting • Reviewing of Legal & Administrative (GMP,CoPP, FSC etc) Documents • Pack insert / PIL – Drafting & Review • Prepare Summary of product (SmPC) and Pack Information Leaflet (PIL) • Prepare label and carton contents • Justification for fixed dose combination • Global Patent Information and Literature for patented product.
Drug Master Files - Pharma. Compilation for open and closed part.
Drug Master File (DMF) is a master document containing complete information on API. The DMF contains confidential information on a drug product’s chemistry, manufacture, raw materials, stability, purity, impurity profile, and packaging. Our services cover Type II DMFs for drug substances (APIs) and Type IV DMFs for excipients (inactive ingredients). All DMFs are prepared in the Common Technical Document (CTD) format stipulated by the FDA. It is a submission to FDA covering factual and complete information on its chemistry, stability, purity, impurity profile, packaging and cGMP status of any API. We also perform the following studies, in co-operations to DMF preparation Structural Elucidation Studies (Elemental Analysis, IR, Mass, MR C & H, XRD, DSC),Analytical Report (COA)Analytical Method ValidationProcess ValidationStability data studiesDetermination & Validation of Potential Impurities & Solvent Impurities. Dossiers Pharma. The ASEAN (Association of Southeastern Asian Nations) have observed this and are now drafting the ASEAN CTD, a standard derived from the CTD.
In place of the 5 modules, the ACTD organized the submission into 4 parts. This is done because ASEAN members usually only receive reference applications — applications to put a drug on the local market that has already been approved elsewhere. As a result, the need for detailed documentation is lessened — most study reports are not required to be submitted.
Module 1 in the CTD (the regional and registration information) is still present as Part I in the ACTD. ICH M2 is dropped and the summaries are absorbed into the subsequence parts. Common Technical Document for ASEAN countries contains of four parts :- Part I : Administrative informationPart II : QualityPart III : Nonclinical Study ReportsPart IV : Clinical Study Reports. CTD Dossier Preparation. The Common Technical Document (CTD) is a set of specification for application dossier, for the registration of Medicines and designed to be used across Europe, Japan and the United States.
Quality, Safety and Efficacy information is assembled in a common format through CTD .The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). eCTD: Its electronic version called electronic Common Technical Document (eCTD) eCTD composed of two types of specificatios Content Specification—-As defined by ICHTechnical Specification—-Electronic Software’s The Common Technical Document is divided into five modules :- Module 1 : Administrative information and prescribing informationModule 2 : Common Technical Document Summaries (Overview and summary of modules 3 to 5)Module 3 : QualityModule 4 : Preclinical Study ReportsModule 5 : Clinical Study Reports (Clinical studies)