To enable and assist our clients with a hassle-free submission process, it was decided to contract Zwiers Regulatory Consultancy as our main strategic regulatory partner. Since last year, non-electronic submissions will not be accepted anymore by the FDA. In combination with an everlasting increase in regulations and standards, which is reflected by initiatives such as CDISC and ICH, a need emerges to structure data submissions to regulatory authorities such as the FDA, EMA and PMDA.
A challenge for many professionals in the (Bio) pharmaceutical industry is the amount of directives and guidance documents to look into. The electronic Common Technical Document (eCTD), which is the required format for registration dossiers, has a modular scope to include quality, preclinical and clinical reports, summaries and overviews. Especially in the final stages the timely readiness of up-to standard documents and a smooth document flow is essential.
In Zwiers Regulatory Consultancy, Viroclinics Biosciences found a solid strategic partner to support the (Bio) pharmaceutical community with regulatory compliant and submission ready documentation. Their expertise in technical and regulatory writing as well as document management and eCTD building allows for swift submission. Zwiers has extensive experience in document management solutions including data room facilities for due diligence.
In cooperation with Zwiers Regulatory Consultancy, Viroclinics Biosciences has composed a tailor-made eCTD platform, focused on submission-ready documentation flows. Key documents include method-SOPS and summary files. This allows for efficient preparation of e-submissions, time & resources reduction and a simplification of regulatory documentation exchange allowing both smooth marketing authorization approval as well as preventing unnecessary post-approval changes and variations.
In Zwiers Regulatory Consultancy, Viroclinics Biosciences found a solid strategic partner to support the (Bio) pharmaceutical community with submission ready documentation.Nicole Houba