It is challenging to find the right level of quality oversight and quality system detail. Good practise dictates that your efforts should be proportionate with the complexity of your operation.
At RegSmart we understand that the quality of the product is based on scientific data and rationales, we understand that a solution must be fit for purpose.
We can help you audit your own operations or that of your suppliers or service providers. We are experts in good manufacturing practice, good distribution practice and safety features (serialisation for EU) with long experience from government inspections both in Sweden and abroad.
Audits may be performed at:
- Manufacturers, packers and importers of medicinal products
- Manufacturers, importers of distributors of active substances
- Excipient and packaging material suppliers
- Wholesalers and marketing authorisation holders
- Logistical service providers
- Providers of computerised systems
- Suppliers of manufacturing equipment
Our consultants can help you with setting up a quality management system, or assist in specific tasks such as:
- Facilitate risk assessments and process mapping
- Training and lectures
- Act as discussion partner to quality management or to a qualified person