Connect the dots paint the picture between your target indication and the clinical, nonclinical, and CMC data to write the story for others to understand
Experts WEB to match development program
Through experience from working with all sorts of experts as a leader in Denmark and internationally in companies like Shionogi, UCB, Genmab, LEO Pharma, Actavis, many small biotech companies, and Atrium/Copenhagen University a WEB of excellent experts is created. Ozack reaches out to experts where needed to make sure we give the best advice for your development program and in your target countries.
Facilitation of smooth process towards milestones
In drug development many different disciplines are required to compile any kind of regulatory document. Ozack can set up a plug-in team with needed experts to evaluate your development program and suggest regulatory pathways and identify GAPs and mitigation plans. Project plans are key to make sure milestones are met. Ozack prepare projects plans making sure all contributors know when to deliver in the relay.
Local agents and experts in JP and US and European countries
Through 25+ years of global regulatory roles in the pharmaceutical industry Ozack has connected and worked with many different experts and vendors globally. Ozack recommend preferred local agents and experts based on this experience.
US Agent: Sandra Cottrell is the preferred US regulatory adviser for Ozack ApS through B&H Consulting
Services in New Jersey, US http://www.bhconsultingservices.com/
Japan Expert: Masami Tamura is the preferred Japanese regulatory adviser for Ozack ApS through CoreMed Corporation in Osaka, Japan. http://www.coremed.co.jp/en/about/.
Accountability & Communication: Per Leth-Nissen at CXOPeople is the preferred adviser for Ozack https://cxopeople.com/
Building Life Science Business in Europe: Takashi Takenoshita at https://livbioconsulting.com/
All expertise areas connected into one meaningful story line
In drug development many different disciplines are required to cover the story line and data recommended for a given product in a given indication. Ozack can set up a plug-in team with needed experts to evaluate your development program and evaluate regulatory pathways and GAPs. We can also simply recommend glue it all together in one project plan.
Accountability for engagement and all deliverables on time
Take ACTION for success – yours and others. If we all attempt to live individual and shared accountability at the same time to achieve the success we want in life, then the world would be a better place and more good solutions will reach patients faster. Ozack strives to always deliver accountability to your project and share your successes and challenges in a proactive way. We make an effort to align expectations on an ongoing basis and aim at excellence in what we do. Science is not enough. The WAY you apply science and communicate is essential to leverage the value of science.
TOPRA (The Organisation for Professionals in Regulatory Affairs)
Dansk Biotek (Danish Biotech organisation)
DIA (Drug Information Association)
Board Assure Alumni
ICC (International Club Copenhagen)
Steering committee of Atrium Regulatory Affairs Education
It is key that Ozack expertise is sharpened every day to be able to offer the best advice. Ozack is therefore a member of a number of organizations globally.