Clinical trial application: PLG’s team of CMC writing teams can prepare the full Identification of Medicinal Products (IMPD) dossier or an Investigational New Drug Application (IND) to support clinical-trials applications. The team prepares the IMPD/IND (with CMC sections of the Common Technical Document [CTD], by following ICH guidelines) from raw data obtained during R&D studies.
The team prepares the Module 3 (CMC sections of the CTD following ICH guidelines) from raw data obtained during R&D studies or updates to a historical dossier in accordance with new regulations. When appropriate, the team can use either PLG’s document templates or a client’s templates and handle both document reformatting and document management. In collaboration with our publishing team, we can deliver the dossier in electronic CTD (eCTD) format. A complete eCTD file—consisting of Module 1 to Module 5—can be created with the help of different departments within PLG.
Quality Overall Summary: The PLG team prepares the summary in accordance with the current Module 3.
Signature of 1.4.1
Our experts have the authority to sign.
We handle all variations, including regulatory positioning, preparation of variation files, and support documentation. The variations include the addition of a new manufacturer of drug substance or drug product, manufacturing-process modifications, changes to specifications (tests and limits) and to analytical methods defined to control the quality of a drug product, changes in packaging, and changes in expiry dates.
PLG also manages variations after the identification of gaps; PLG defines the type of variation; and PLG writes the full variation package, including expert signature if needed (1.4.1).
Assessment of regulatory impact of the change control process
Electronic application form for variations
Updating of complete marketing authorization file according to current regulations
ASMF/DMF/CEP, Module 32S, submission to the European Directorate for the Quality of Medicines & HealthCare (EDQM) or to the competent authority via the Common European Submission Platform (CESP)
Module 32P, QOS. Certified Product Information Document Chemical Entities (CPID-CE) for Canada, Normative Document (ND) for Russia
Submission to competent authorities
Responses to questions from authorities
Writing answers based on the submitted documentation and new information
Reformatting and baselines of old application dossier to non-eCTD electronic submission (NeeS)/e-CTD
Creation of new files to resolve discrepancies that arise when data is gathered from several sources, preparation of guidelines to fix the final structure of a dossier, and reformatting of the document in CTD or eCTD format, also taking into account the client’s specific requirements with regard to templates and phrasing. The reformatting is performed by the data management team. The publishing team compiles the documents and edits the sequences.