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Regulatory strategy and procedural support
Your key to a succesful strategy and execution
A good definition and execution of the regulatory strategy is critical to enable successful and timely commercialization of a medicinal product. Qdossier provides both strategic and procedural support to enable pharmaceutical companies successfully realize their goals.
Ensure succesfull and timely commercialization
A good regulatory strategy is critical to enable succesfull and timely commercialization of a medicinal product. Defining and executing the regulatory strategy requires a good and comprehensive understanding of the regulatory framework in the country(ies) of interest.
Qdossier Consultancy supports both emerging and established pharmaceutical companies in defining and executing strategic regulatory activities, including:
· Considerations for the establishment of a company
· Applying for a recognition as a micro-, small- or medium-sized enterprise (SME)
· Identifying regulatory filing strategies (e.g. expedited or reliance pathways, EU national, mutual-recognition or centralized procedure)
· Filings for Orphan Drug Designation (ODD) applications
· Preparing for Scientific Advice meetings and necessary briefing packages
· Preparing for Pre-submission meetings
· Preparing and filing for Marketing Authorization Applications (MAAs) and follow up submissions
· Strategic planning for post-approval development and product maintenance
A scientiffic and pragmatic approach
By raising the question ‘What’s in there for the patient’ and by going back to the core of your product and data, Qdossier guides you to the right strategy. This leads to a pragmatic (so not dogmatic) interpretation of regulatory guidance and understanding of the original intention of the requirements. Using sound arguments supported by science, vision and reliable data, Health Authorities will become your best friend in safeguarding patients.
'Hope is not a strategy'
Vince Lombardi
American football player
(Hands-on) procedural support and informed decision making
Managing regulatory procedures requires specific skill sets and time. Regulatory professionals from the applicant and/or Marketing Authorization Holder (MAH) can run these procedures. However, sometimes the applicant/MAH lack that specific knowledge and/or time. For example, what procedure should be selected in the EU (NP, DCP, MRP, RUP, CP)? What Marketing Authorization type do we apply for (e.g. Full, Generic, Hybrid, Established use, Biosimilar, Informed consent)? Qdossier can inform you what of the options would qualify and what the pros and cons will be.
From the Netherlands we can easily communicate with all national competent authorities worldwide and with EMA. Qdossier is familiar with the various procedure types in the EU (National, Decentralised, Mutual Recognition and Centralised). Also the EMA and various associated committees (e.g. PDCO, PRAC, CHMP, CAT, SAWP and QRD) can be approached through us. So, if you do not have the time or would like to have our help, we can be your contact person on behalf of your company.
We help you preparing cover letters, application forms and other details for appropriate, correct and consistent information. We help you with the selection of variation types, supportive documents and conditions and that the correct wording is used to qualify for the variation classification.
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.