Swift FDA and EMA submission guaranteed with eCTD platform
Viroclinics Biosciences and Zwiers Regulatory Consultancy are partnering to ensure regulatory compliant and submission-ready documentation. Their eCTD platform allows smooth preparation towards marketing approval and prevents unnecessary post-approval changes.
The complex and increasing set of requirements and regulations, urges companies to structure data submissions to regulatory authorities such FDA and EMA. Viroclinics has extensive experience in providing up-to-standard SOPs for analytical methods (i.e. method-SOP). Zwiers has the expertise to transfer these into regulatory compliant documents in line with all electronic Common Technical Document (eCTD) requirements. In this way, Viroclinics and Zwiers together ensure documentation that is not only of high technical quality, but that can also be directly included in the eCTD enabling swift submission and easy updating. “In Zwiers Regulatory Consultancy, Viroclinics Biosciences found a solid strategic partner to support the (Bio) pharmaceutical community with submission-ready documentation“, Nicole Houba, Director QA of Viroclinics BioSciences, states.
Zwiers Regulatory Consultancy provides regulatory and pharmacovigilance support for pharma and medical device companies. Their expertise in technical and regulatory writing as well as document management and eCTD building facilitates swift submissions. Zwiers has extensive experience in document management solutions including data room facilities for due diligence.
Viroclinics BioSciences is a leading diagnostic and clinical trial operation service company supporting clinical and preclinical studies for drug and vaccine development for prevention and treatment of virus infections. In cooperation with Zwiers, Viroclinics’ regulatory team has composed a tailor-made submission-ready documentation flow with high quality method-SOPS being made submission-ready. This allows for efficient preparation of e-submissions and reduces time and resources. The eCTD platform facilitates smooth marketing approval and prevents unnecessary post-approval changes and variations.