Regulatory Affairs
We work in a complex and challenging market, where the products we make can directly impact the quality of peoples lives. Unsurprisingly, there are rules to ensure that these products maintain the highest standards - but these do vary from nation to nation, which can sometimes make getting the appropriate licences for each particular market a complicated and confusing process.
ABC can help you make sure this is as painless as possible, right from the beginning of your project through to getting your product to market. Whether it's early specification of testing, requirements in the design of your product, documentation or submission to the relevant competent authorities, we can support you. We have the knowledge and experience for a wide variety of markets including Europe, North America, Canada, Australia, Russia, Brazil and Japan. Design Dossiers, CE marking and technical file reviews
The documentation of your product is not only critical to support its launch in your target markets, but will also affect your ability to continue to sell in these markets as the regulations and requirements change (which they invariably will). At ABC, we consider Change Management central to our approach. Let us guide you through the definition and development of robust documentation that will support your business goals through the entire product life cycle. |