Our team of CMC specialists is here to help you manage your product’s compliance at every step – from clinical development, to market authorization, and far beyond.
We help you navigate a range of critical regulatory milestones and checkpoints, including site registration, product registration, and post-approval inspections, audits, and changes.
Partner with us during your product’s development, and your team will benefit from a smooth, proven process for managing the Common Technical Document (CTD) in key initial submissions:
Throughout our 40+ year history as a global CDMO, we have established a solid success record with regulatory agencies worldwide – including in the US, EU, and Japan. We currently manufacture over 110 products approved by the FDA and EMA alone.
Throughout the year, our facilities also undergo regular inspections by national and internal authorities. Over the past decade, we’ve been successfully inspected by nearly every regulatory body around the globe, including both routine cGMP and pre-approval inspections (on-site and paper-based).
In our role as combination product manufacturer, we are experienced in navigating the complex regulatory pathways that device-based injection systems must undergo before they can enter the market based on the following regulatory frameworks (depending on the market in which the combination product is to be approved):
At Vetter, we always strive to continuously optimize our systems and processes to enable consistently high-quality manufacturing of our customer’s drug products and compliance with international regulations like the US Code of Federal Regulations (CFR) and the EU GMP Annex 1.
Wolfgang Weikmann, Senior Vice President Quality
Our Regulatory Affairs team has broad knowledge and experience in CMC, cGMPs and Quality matters, enabling regulatory compliance and smooth submissions across your injectable product’s life cycle.
Katja Kotter, VP Regulatory Affairs/Quality Compliance
