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A-pharmaconsult documentation and dossier support
A key part of A-pharmaconsult’s offer of consultancy services to support pharma manufacturing and medical devices concerns the detailed preparation of documents and regulatory submissions, including pharmaceutical marketing authorization dossiers, technical dossiers with all the required technical documentation for medical devices, and cosmetic product information files (PIFs).
A-pharmaconsult regulatory experts can work in close partnership with clients to manage the complexities of regulatory documentations and quality control to ensure more effective dossier submission by maintaining quality and compliance for drug and medical device products.
Common Technical Document (CTD)
The agreement to assemble all the Quality, Safety and Efficacy information in a globally harmonized Common Technical Document (CTD) has revolutionized the pharma regulatory process and improved review practices. However, it requires expert knowledge and careful document management to use the process successfully.
The EU CTD dossier is organised into five modules, with the first (Administrative and Prescribing Information) being region specific and the other four (Summaries, Quality, Nonclinical Study Reports, and Clinical Study Reports) being common to all markets.
The same CTD rules apply to the electronic version of the M4 CTD, the eCTD, that allows online submission of regulatory information, and which has now become mandatory for all marketing authorizations applications (MAAs) in Europe.
Although in digital format, the eCTD is governed by rules as rigorous as the paper version and requires careful management and knowledge to ensure the document control process is managed successfully.
A-pharmaconsult drug-related services include preparation and maintenance of Marketing Authorization Application (MAA), gap analysis, research and writing services covering summaries and overview, clinical and non-clinical modules, chemistry manufacturing controls (CMC), regulatory strategy, product information, and expert reports.
An experienced regulatory team supports clients in preparing gap analysis and updating the regulatory documentation for their drug products.
Gap identification and assessment of potential regulatory implications allows clients to take preventive measures to ensure regulatory conformity with EU and other requirements.
Effective marketing of Medical Devices requires full control of related Technical Documentation, MDR 2017/745 and Quality Management System (QMS). In this field, A-pharmaconsult can offer smooth transition to compliance with the new European medical devices standard EU MDR 2017/745. This includes preparation and maintenance of MDR Technical Documentation.
Effective from 2013, the EC Cosmetics Regulation 223/2009, requires responsible persons representing cosmetics manufacturers to compile a Product Information File (PIF) for each marketed product placed on the market. The PIF is the repository for all relevant product detail and history. The PIF must be maintained for ten years from the final batch being marketed date and is subject to frequent checks.
A-pharmaconsult’s cosmetics team can help clients ensure their PIFs contain any information within the technical documentation needed to substantiate manufacturing of the product, claims, plus accurate summaries, and declarations of safety, etc.
A-pharmaconsult has developed toolkits that enable its teams to manage the compliance of their clients’ products from initial R&D to dossier preparation and onwards, through entire product lifecycle.
QMS – Quality Management Systems
For pharma or biopharma manufacturers, production of a pharmaceutical dossier that complies with European and/or International standards, and ICH guidelines must also be guided by a Quality Management System (QMS) that meets relevant quality guidelines requirements.
For the medical device industry, the QMS should accord with ISO 13485:2016 and sometimes MDSAP standards, with the device description and specifications based on Annex II 2017/745 MDR technical documentation rules.
For cosmetics, the QMS should comply with ISO 22716 standard.
A-pharmaconsult can also support for the Implementation / Compliance of Quality Management System: writing of quality documentation, QMS documentation management, training, audits, management of complaints, change controls and other nonconformities.
Click on A-pharmaconsult Regulatory Affairs Services for further information.