LINK assists in the preparation, assembly, validation and submission of Marketing Authorisation Applications.

We help you choose the most appropriate application procedure (centralised, mutual recognition, decentralised, national)  as well as the type of application e.g. complete or bibliographic, generic, hybrid, traditional use and we liaise with the competent authorities.
 
LINK helps you to compile the regulatory documents necessary for your Marketing Authorisation Application as required in the Notice to Applicants and relevant guidelines. Our Regulatory Affairs Associates are experienced in preparing the documents required for the different modules of the dossier, e.g; 

• Chemistry, manufacturing and control (CMC) documents, including quality overall summaries (QOS)
• Pre-clinical overviews and summaries
• Clinical overviews and summaries
• Product information texts, e.g summary of product characteristics, package leaflets and  labelling texts

 We can also provide assistance in writing responses to assessment reports from the authorities and relevant sections of your dossier in response to assessment reports.
 
If desirable, we can communicate with the authorities on your behalf during the application process.

As a Scandinavian CRO ( Contract Research Organisation) with offices in Oslo, Stockholm and Copenhagen we provide you with local expertise.