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Due diligence of regulatory dossiers
Appropriate attention for documented evidence
Our consultants critically assess data completeness, correct data placement, appropriate definition of the study subject, the scientifically relevant effect and the validity of its measurements.
Balancing gains, risks and failures
In-licensing or buying a product (NCE, biopharmaceutical, generic, biosimilar or ATMP) is a tedious task whereby the financial gain, risks and failures should be balanced during a due diligence on regulatory dossiers.
One might do that for marketed products, products under review by authorities and development products. Reviewing existing dossiers is an important task to predict the chances for an approval letter and/or indicate the gaps to be resolved to assure a marketing authorization. Our consultants critically assess data completeness, correct data placement, appropriate definition of the study subject, the scientifically relevant effect and the validity of its measurements.
Evaluating registrability
When buying, we identify gaps in documentation and/or corrective and preventive actions (including additional studies) where needed. Two or three days intensive scrutiny of dossiers (preceded by a thorough preparation) gives a fast return on investment. Our experts will apply their knowledge and expertise on regulatory dossiers offered for due diligence on regulatory dossiers (from a seller and buyer perspective). Evaluating the registrability of a product through its supporting documented proof is our strength. Therefore, our team helps you with informed decision making.
Increase product value when selling
For those who want to sell a product, the offering a transparent dossier of a high-quality drug with a favorable benefit-risk profile will increase a product’s value. The return on investment can be enormous. For improving the transparency of the dossier and increasing the chances for approval, you can leverage from our support in lean authoring and transparent and consistent publishing services. Together with Qdossier’s due diligence on regulatory dossiers this assures a good value for money when buying or selling licences.
A good definition and execution of the regulatory strategy is critical to enable succesfull and timely commercialization of a medicinal product. Qdossier provides both strategic and procedural support to enable pharmaceutical companies succesfully realize their goals.
The production of eCTDs require a special skill and tool set… and a comprehensive understanding of the purpose of a dossier combined with future vision. Qdossier offers all of that through its qualified team members and standardized procedures; mostly remotely (inshore or offshore) and onsite when needed.
Qdossier writers have the skill set to provide the information in an unambiguous way; meaning that factual information will often be provided in tabular formats and bulleted lists, rather than narratives.