Softlex can resource various Regulatory Affairs projects for the pharmaceutical industry - from file submissions to more complex management of compliance issues and post-licensing activities.
We have experience in this field and can supply the market intelligence and consultants to match Regulatory Affairs needs.
We are up to date with current legislation, regulatory requirements, industry initiatives and interpretations of the regulations.
Switching a prescription drug to an OTC product is more and more considered by many pharmaceutical manufacturers. In order to do such switch requires knowledge and practical experience of the OTC regulations. Softlex can help with both prescription to OTC switches or with products developed for the OTC market.
We offer full management of OTC medicines.
Either you have a generic medicinal product or you have an older molecule that has a well-established use, Softlex can generate all the necessary regulatory documentation and drive these through the assessment and approval process to get your product to market.
Whichever the application you have in mind, being National, Mutual Recognition, Decentralised, Centralized, Generic, Bibliographic or Hybrid Applications – we ca provide strategy advice in order that most suitable solution is chosen.
Softlex is offering services in licencing Food Supplements either under Ministry of Health or under Institute of Food Bioresources notification.
Softlex provides consulting and contract services registration of medical devices. Our consultants have experience in all aspects of this field and can provide expertise in the registration of Class I, II or III medical devices.