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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 succesful and timely commercialization
A good strategy is critical to enable the successful and timely commercialization of a medicinal product. Defining and executing a 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
· Identifying a strategy for filing (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 scientific 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 in 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 the correct wording that is used to qualify for the variation classification. In addition, our Documents- and Dossier team can take care of the end-to-end publishing and submission of your regulatory dossiers.
SME (Small and Medium-sized Enterprise) representation
Qdossier obtained the EMA SME status, meaning we are eligible to benefit from provisions for financial and administrative assistance for SMEs, as laid down in Regulation (EC) No 2049/2005.
What is SME status and what does it mean for our customers?
To promote innovation and development of new medicines, EMA supports micro-, small- and medium-sized enterprises (SMEs) by providing incentives during pre-marketing as well as post-authorization procedures.
Qdossier can support non-European Economic Area (EEA) based enterprises by accessing these incentives granted by EMA through the Qdossier SME status. This means that you, as an SME customer, can access several benefits e.g., EMA fee reduction for scientific advice, inspection procedures, pharmacovigilance and administrative services.
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.
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.