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Regulatory Support
We are fully committed to be the best, objective-focused partner in the research and delivery of innovative solutions to support the success of our customers.
Regulatory Support
We are fully committed to be the best, objective-focused partner in the research and delivery of innovative solutions to support the success of our customers.
In an increasingly demanding regulatory environment, the Regulatory Affairs team is dedicated to helping customers with regulatory inquiries and supporting them with their regulatory submissions to secure their projects and optimize time-to-market.
The team is composed of regulatory affairs professionals, experienced in drug delivery devices, and Incontinence Healthcare, with a global presence.
The Regulatory Affairs team has extensive experience in performing license maintenance activities on a worldwide basis. The function not only fulfills the license holder’s obligations, minimizing future compliance risks but also successfully realizes additional revenue streams for marketed products through line extensions, product reclassification, and new market approvals.
Regulatory team members are responsible for:
Keeping track of the ever-changing legislation in all regions where a company distributes or wishes to distribute its products.
Advising on legal and scientific restraints and requirements
Collecting, collating, and evaluating scientific data.
Presenting registration documents to regulatory agencies and carrying out any subsequent negotiations necessary to obtain or maintain marketing authorization for the products concerned.
Giving strategic and technical advice at the highest level in the company, making a significant contribution both commercially and scientifically to the success of a development program and the company as a whole.
Helping the company avoid problems caused by poorly kept records, inappropriate scientific thinking, or poor presentation of data.
Additionally, the regulatory affairs department regularly participates in the development of product marketing concepts and product development. It is commonly required to approve the design and labeling before the commercial launch.
Regulatory Regulations, Standards, and Guidelines applicable to containers and devices are numerous, evolving, and complex to apply. New MDR Medical Devices Regulation increases the need for our customers to have a reliable partner, well prepared, and structured with robust product development and manufacturing processes established.
The Regulatory Department can provide expertise, consultancy, and data concerning our products' most critical topics. These include extractables and leachables, biocompatibility, sterile barrier effect, and packaging validation for finished sterile goods, stability studies according to the most updated version of applicable Harmonized and Recognized Standards.
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355 Longjin Road, Changzhou Economic Development Zone, Jiangsu Province, China
