Regardless of the company making the physical product, it’s the company with the name displayed on the label that must ensure that the product reaching the consumer shelf (whether physical or online) meets the regulatory parameters and compliance requirements as set out by national or country-specific authorities. Full-service suppliers or CDMOs (contract development and manufacturing organisations) almost always include market support to ensure the product you wish to launch is compliant with the target countries of retail. In the case of ordinary CMOs (contract manufacturing organisations), manufacturers should at least be able to provide recommendations for declaration or compliance with particular guidelines.
In the case of private label manufacturers, PharmaLinea, which provides ready-to-launch products, Klopčič shares that clients repeatedly encounter the same challenges, which is why the business has a team dedicated to supporting clients in their product registration process, whilst simultaneously collecting knowledge and best practices from previous cases in order to assist new clients.
“Naturally, brand owner companies are the experts on their local regulatory environment, but the principles and obstacles are somewhat repetitive across markets and our experience can help expedite problem-solving,” Klopčič says.
The questions you need to ask to find a contract manufacturer