Regulatory Consultancy and Strategy
CREATE VALUE THROUGH ACCOUNTABLE COMMUNICATION
with regulatory stakeholders
between people
NEWS FROM OZACK
Ask patients to look through your clinical protocol before start – this will increase chances of success in meeting their unmet needs!
CREATE VALUE THROUGH ACCOUNTABLE COMMUNICATION
with regulatory stakeholders
between people
NEWS FROM OZACK
Ask patients to look through your clinical protocol before start – this will increase chances of success in meeting their unmet needs!
Regulatory pathways & global strategy
GAP analysis
Precedence within therapeutic area and technology
Intelligence to apply
Regulatory guidances
Regulatory regulations and directives
Overview of competitor products
Recommend topics for Agency interactions
Prepare regulatory documents (TPP, IB, CTA, IND, ODD, Fast Track etc.)
Looking at the snapshot of MAs granted in EU between 2010 and 2012, 94 products contained a New Active substance– and of these 94 MA holders, 13% were SMEs. What is even more striking, 27% of these products originated from the SMEs, highlighting their important role particularly in the upstream phases of pharmaceutical innovation.
Experts WEB to match development program
Collaborators facilitation of smooth process towards milestoner
Local agents and experts in JP and US and European countries
All expertise areas connected into one meaningful story line
Accountability for engagement and all deliverables on time
Membership of TOPRA, DIA, Dansk Biotek, BioPeople, Board Assure Alumni, ICC (International Club Copenhagen)
” Every day ask yourself: What else can I do to achieve the success we want in life? ”
Agency Advice
- When and how to ask
- Briefing Documents
- Rehearsal for meetingsTraining on
- Success through accountability in teams
- Regulatory topicsDue Diligence
- Readiness for due diligence
- Perform due diligenceBoard Meeting
- Risks and Mitigation Strategies
- Communication tools for BoD meetingsInvestors
- Value inflection points through regulatory actions
Stepping into clinical trials and beyond means entering a very regulated area with options and pitfalls. Ozack can help you get there and ensure value is created through regulatory agency interactions at every step.
In Ozack we strive to live by the OZ principle which means to take accountability for individual and shared success and to stay above the line by being positive and thinking solutions to any challenge. We reach out, seek understanding, give helpful advice and take part in the solution. Every challenge is an opportunity!
Ozack has SME status in EU which enable close communication with EMA on behalf of all clients.
Ozack experts consist of the founder Ann Christine Korsgaard with 26+ years of experience and a “WEB” of experts connected to Ozack.
