CREATE VALUE THROUGH ACCOUNTABLE COMMUNICATION

with regulatory stakeholders

between people

Ask patients to look through your clinical protocol before start – this will increase chances of success in meeting their unmet needs!

ozack_neg

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!

ozack_neg

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.)

bobelbillede

RhoVac recently announced that they are planning a pre-IND meeting with the US Medicines Agency for a phase IIb study of the company's cancer vaccine RV001

  • 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)

RØDRING

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 meetings

  • Training on

    - Success through accountability in teams
    - Regulatory topics

  • Due Diligence

    - Readiness for due diligence
    - Perform due diligence

  • Board Meeting

    - Risks and Mitigation Strategies
    - Communication tools for BoD meetings

  • Investors

    - Value inflection points through regulatory actions

mariehøne

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.

blåblomst

“Inspiring, visionary, energetic, hardworking, generous and a fantastic communicator who truly loves and lifts people. Result-oriented networker, who transforms love to gold through her high level of emotional intelligence. That is Ann Christine.”

Per Leth-Nissen

President & CEO, CXOPeople

“Ann Christine is a highly talented and experienced regulatory expert with a refreshing and energizing working style. She is a joy to work with and consistently delivers results of very high quality, within the agreed time frames.” 

Jan van de Winkel

President and CEO, Genmab AS

“Ann Christine always provides qualified and on time help to the complicated regulatory process especially when it relates to biologics."

Claus Møller

CEO, Y-mAbs Therapeutics, Inc.

“Flexibility and commitment combined with experience and professionalism was how Ann Christine ensured that our project was regulatory compliant and completed on time.”

Anders Ljungqvist

CEO, RhoVac AB

Ozack ApS
Ole Maaløes Vej 3
2200 Copenhagen N
Mail: ack@ozack.dk
Phone: +45 25 40 30 00