Our senior regulatory associates are experienced in drug development and
validation of regulatory documents. They can advise you through the
drug development phase, from product concept to submission of the
marketing authorisation application.
Our services include:
- Regulatory advisory services
- Assessment of suitability of available documentation, e.g.
chemistry, manufacturing and control (CMC) documents, pre-clinical data
and clinical data in terms of quality and compliance with guidelines
- Choosing the most appropriate application procedure
(centralised, mutual recognition, decentralized or national) as well as
the type of application (e.g. complete, bibliographic, generic, hybrid
or traditional use)
- Establishing product development plans for the pharmaceutical
development phase, the pre-clinical phase and/or the clinical phase
- Preparation of pre-submission meetings and scientific advice/protocol assistance
- Rx-to-OTC switch strategies
Preparation of dossiers
LINK Medical assists in the preparation, assembling, validation and submission of your application dossier.
We will help you to compile the regulatory documents required for
your dossier (such as MAA, NDA and IMPD), as required in the relevant
regulations. Our regulatory associates are experienced and know exactly
how to prepare the documents for your dossier.
- Chemistry, manufacturing and control (CMC) documents, including quality overall summaries (QOS)
- Pre-clinical overviews and summaries
- Clinical overviews and summaries
- Product information texts, including summary of product characteristics, package leaflets and label texts
- User/readability testing of package leaflets
- Managing source documents in a secure and web based regulatory Document Management System (MasterControl). Possibilities for external access
LINK Medical can communicate with the authorities on your behalf
during the application procedure and assist with the responses to
Post approval support/maintenance work
LINK Medical takes care of all the steps involved in maintaining marketing authorisations, for example:
- Transfer of marketing authorisations
- Periodic safety update reports (PSURs)
- Updating summary of product characteristics (SPCs), label texts and package leaflets
- Proof-reading of labels and leaflets
- Catalogue texts, such as Felleskatalogen or FASS
Our regulatory associates have experience from a variety of therapeutic
disciplines and can easily consult experts within the different areas.
We focus on linguistic accuracy, as well as regulatory compliance with mandatory
templates, such as quality review of documents (QRD) templates.
- Compile, publish and validate eCTD, NEES and VNEES submissions in Europe
- Fully Electronic subissions via portals (CESP, EMA Gateway)
- Granularity of documents for eCTD
- Support and use of eCTD ready document templates
- Converting Non-eCTD electronic format (NEES or paper) to eCTD format