Quality Assurance Vs Regulatory Affairs – We have established a world-class quality system, quality control and operational system that meets or exceeds the international regulatory standards of the FDA, EMA, NMPA and other major US regulatory agencies. Starting with the Chief Executive Officer, our commitment to quality is ingrained in the culture of our company and our employees, and we have integrated our quality assurance (QA) and quality management systems. anywhere in the world for the production of biologicals and vaccines for medical or commercial purposes. medicines and medicinal products.
Our commitment to quality is one of the pillars of our success as it enables our customers to introduce new biotherapeutics and vaccines into the clinic and beyond. To learn more, watch the video that describes the global high quality system.
Quality Assurance Vs Regulatory Affairs
All GMP manufacturing operations follow global regulations and guidelines, including those of the FDA, EMA and NMPA. We currently have 14 raw material and drug manufacturing facilities and a quality control testing laboratory that has received GMP certification.
Quality Assurance Vs. Quality Control In The Medical Device Industry
We have completed over 1,000 GMP/quality certifications and continue to strive and meet their quality expectations.
We have passed 30 inspections from many government agencies worldwide, including the US FDA, EMA, NMPA, PMDA, MFDS, HSA, ANIVSA, HPRA and Health Canada.
We have enabled our clients to obtain 45 product licenses and EU approvals in relation to BLA/MAA/EUA applications for over 10 products and from over 10 regulatory agencies.
Using our DNA IND biologics development and manufacturing platform, we have successfully helped our clients around the world successfully file more than 440 Investigational New Drug (IND) applications since 2015.
Pharmaceutical Regulatory Affairs Consulting｜cm Plus Corporation
WuXi Biologics uses ALCOA+ data integrity principles, an extensive employee training program, and an unwavering commitment to protecting our customers’ assets as key elements in our ability to provide high quality systems. global standards that enable our customers to deliver new biologics and vaccines. for the benefit of patients worldwide.
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We not only take care of quality management, but also support you throughout the lifetime of the medicines legislation.
Learn more about the audit services QbD Group provides to the pharmaceutical and biotech industries in this free brochure.
Quality Assurance / Regulatory Affairs Officer
A team of expert CMC authors is required to convert the data on the development, design and manufacture of the active ingredient and/or final dosage form into a suitable document that can be submitted to the regulatory authority for review and approval. QbD can help you write the appropriate quality module in the CTD based on the stage of your medicine, whether it is in the clinical stage or in the process of applying for a license. the trade. Experts can perform the necessary literature review and prepare appropriate professional reports.
We support you in submitting an application for a license to sell medicines with new or known active ingredients, with or without innovation (generics). Especially for new drugs, the approval process can be complicated and time-consuming. This is where our case management team can coordinate the preparation of meetings with the authorities (scientific advice, preliminary submissions, clarifications, requests for ATMP or orphan classification).
Once approved, the marketing authorization must be maintained and continuously updated to ensure that the manufacturing process approved in the document is in accordance with the situation in the production facility.
Our RA team can support you in bringing your medicine to market and maintaining your marketing authorization for life. Post-approval activities (such as renewals, changes, annual product reviews, Article 57 data, transfers, etc.) are handled by our Regulatory Affairs team.
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Our consultants provide a wealth of knowledge and experience in pharmaceutical and biotechnology matters. We have the knowledge and skills to support your team or deliver a comprehensive legal project – all efficiently and pragmatically.
Services for pharmaceutical and biotechnology matters include writing and drafting registration files according to the laws of different countries and entering all the necessary (technical) data.
Come and see Groupe QbD at stand no. 3G73 at the CPHI conference in Barcelona. And after the conference… Dine and network with life science experts at QbD’s CPHI Networking Drink.
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