Together we make change that matters
Regulatory consultancy that helps you
WORK WITH OZACK
Engaging in drug development means entering a highly regulated area with countless options and hidden pitfalls.
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Ozack can help you ensure value is created at every step.
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We also have extensive experience and an established network of subject matter experts ready to step in when needed.
REGULATORY INSIGHTS FROM THE TEAM
Christina Hemmingsen
A period of market exclusivity after your drug’s marketing authorisation is critical for novel pharmaceutical product since the length of the exclusivity directly impacts the value of your asset. There are different types of exclusivities and protections to be granted; specifically for the US market, you may be eligible for Patent Term Extension (PTE) of maximum 5 years, provided it does not result in total remaining patent term of more than 14 years post-approval. The calculation of the term granted is fairly complex, but heavily relies on the dates of your Investigational New Drug (IND) application filing and issuing of the Patent for which you will seek your PTE. The complexity of the process is only one of many reasons why patent filing and timing of IND submission should be included in your Regulatory Strategy.
OUR EXPERIENCE
oncology, dermatology, diabetes, haemophilia, obesity, pain, neurology, growth disorders, stroke, inflammatory diseases....
70+ years of experience
oncology, dermatology, diabetes, haemophilia, obesity, pain, neurology, growth disorders, stroke, inflammatory diseases, diagnostics, haematology, epilepsy, osteoporosis
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oncology, dermatology, diabetes, haemophilia, obesity, pain, neurology, growth disorders, stroke, inflammatory diseases....
50+ development projects
antibodies, small molecules, biologics, vaccines, drug-device combinations, ATMPs
EU & EEA, UK, USA, Canada, Japan, Australia, South America, China, Asia, Turkey, Russia
oncology, dermatology, diabetes, haemophilia, obesity, pain, neurology, growth disorders, stroke, inflammatory diseases....
30+ countries
EU & EEA, UK, USA, Canada, Japan, Australia, South America, China, Asia, Turkey, Russia
NAVIGATE
oncology, dermatology, diabetes, haemophilia, obesity, pain, neurology, growth disorders, stroke, inflammatory diseases....
Global Strategy
Ozack will evaluate the regulatory options for your type of product with the end in mind, including the milestones on the way towards your labelled target indication. The options and tactics will be described in a global regulatory strategy. It will address priority markets and include a risk assessment of regulatory success. We will explain pros and cons of the different options to guide you to the best path. It is okay to take risks – we will make sure you know what they are before choosing a pathway.
oncology, dermatology, diabetes, haemophilia, obesity, pain, neurology, growth disorders, stroke, inflammatory diseases....
GAP Analysis
We engage with your project by digesting the available data and putting them into context of your next step in the development, whether it is your first clinical trial, or marketing authorization application.
oncology, dermatology, diabetes, haemophilia, obesity, pain, neurology, growth disorders, stroke, inflammatory diseases....
Regulatory Intelligence
Precedence: Ozack can extract and interpret publicly available regulatory documentation for product in development and in the market.
oncology, dermatology, diabetes, haemophilia, obesity, pain, neurology, growth disorders, stroke, inflammatory diseases....
Agency Interactions
Ozack will recommend key topics to be discuss with the Agencies, based on the GAP analysis, regulatory intelligence and next steps in drug development. It is important that the number of uncertainties in your program is minimized. Scientific Advice is an excellent tool to do so.
''Every day ask yourself: What else can I do to achieve the success I want in life?''
CONNECT
Prepare Regulatory Documents
Ozack can help you connect the dots and to efficiently communicate your science to the regulators. Your story must be consistently told across disciplines which are compiled into a submission dossiers.
Network of experts
Ozack involves experienced subject matter experts to provide the best knowledge specific to your development program. We can set up a plug-in team with needed experts to evaluate your development program, identify GAPs and mitigation plans.
Membership
It is key that Ozack expertise is sharpened every day to be able to offer the best advice. Ozack is therefore a member of several organizations globally: TOPRA (The Organisation for Professionals in Regulatory Affairs) - Dansk Biotek (Danish Biotech organisation)
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.
COMMUNICATE
Agency Advice
Regulatory strategy reveals the topics and timing of any Agency Advice. For each Advice, Ozack will establish the framework, and you guide towards the most optimal outcome.
Due Diligence
We can perform regulatory assessment of a drug on your behalf, if you need to evaluate the regulatory potential of a licensing opportunity. Data has no value if it is not properly documented and well organized for someone to assess and take over. At the stage of Due Diligence, it is key to have things in order to
Investors
Regulatory interactions are key inflection points of value for investors. Ozack will make sure the regulatory activities contribute optimally to your fundraising activities throughout your development program.
Stakeholders
Ozack provides clear communication on regulatory strategy and development plans, suitable to be presented to Board of Directors, and other stakeholders. We deliver project plans, with key milestones to demonstrate progress in your development. Ozack will use the project plans to ensure all contributors and deliverables are on track.
