Pharmaceuticals
Artixio provides end to end services from product conceptualization to post marketing maintenance for our clients to commercialize their Novel Therapies, Biologics, Biosimilars, Generics and APIs in global markets. We are an integrated commercial and regulatory services company supporting our clients through their journey of pharmaceutical commercialization.
Regulatory Strategy
Artixio has experience in providing insightful, efficiency regulatory strategy for your pharmaceutical products in global markets. Our strategy aims at developing critical path for products registration to maximize commercial potential by reducing time to market and expanding to multiple regions. Our regulatory strategy support evaluates 360 degree information on product including,
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Product therapeutic area landscape, intellectual property and competitor landscape
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Product's clinical development roadmap
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Country regulatory intelligence and past experience
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Insights based on Health Authority interactions in the country
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Business objective and product strategy
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Product landing price and cost of revenue
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Regulatory and product commercialization risk assessment
Regulatory Affairs
As a full-scale, global regulatory services provider for pharmaceutical industry, Artixio offers advisory, scientific writing and execution support in obtaining successful registration for drugs from health authorities worldwide. Our regulatory affairs services encompass,
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Pharmaceutical products registration strategy
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Medical/Clinical and Non-Clinical/Technical Writing for Clinical and Quality Modules
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Dossier Gap Analysis
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Dossier Preparation and Submission
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Pre-Submission Meetings with Health Authority
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Response to Health Authority Queries, Negotiations
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Obtaining successful approval and licenses
Our experts are based in global locations providing regional support in applicable language and Health Authority experience such as with US FDA, EMEA, MHRA, ANVISA, ANMAT, COFEPRIS, SFDA, HSA, Health Canada, TGA, CDSCO and others.
Regulatory Operations
Artixio provides flexible and scalable operations services to support regulatory functions in pharmaceutical organizations. Our business models include project based support, ad-hoc requests and providing managed services through Full Time Equivalent (FTE) resources based in global locations. Our regulatory operations services include,
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Publishing Operations Consulting
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Bookmarking and Hyperlinks
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Document Level Publishing
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Submission Level Publishing
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End to End eCTD Publishing
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Regulatory Information Management
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Regulatory Document Management and Coordination
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Change Management and Stakeholders Coordination
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Product Lifecycle Management (Variations, Renewals and License Transfers)
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Project Management
Artixio's Global Operations Excellence Centers are centralized with teams based in Germany, India and USA.
Labeling & Artwork
Our end to to end labeling and artwork services support compliance driven labeling content authoring, graphic design and printing for pharmaceutical products. With teams experienced in managing clinical and commercial labeling for diverse products, Artixio provides high quality services to supporting our clients' labeling and artwork requirements.
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Target Product Profile
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Core Data Sheet Authoring and Management
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Core Safety Information Authoring
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Literature Search and Review
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Medical Writing
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Labeling Operations Management
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International Labeling
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SmPC, PIL Support
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Artwork Proof Reading (SmPC, PIL, Blister Packs, Cartons etc.)
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Graphic Design
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Artwork Change Management
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Artwork Process Coordination
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Labeling and Artwork Project Management
Artixio's Labeling and Artwork Professionals are based in USA, Europe and India.
Market Access
Enabling patients’ access to therapies requires authorization from health authorities and payers’ acceptance of pricing based on therapy’s benefits and advantages over existing options. The pricing is driven by insights from key opinion leaders, prescribers’ understanding of the therapy, payers’ policies and regulatory framework on certain disease areas in the country.
The key benefits and advantages over existing treatments are part of drug development planning and therefore, it can be stated that Market Access is a key consideration right from the early stage of drug development.
Artixio’s team brings wealth of experience across complex therapeutic areas and global markets to help you address key questions for your market access strategy. Read about our services here.
Market Intelligence
Artixio enables data driven executive decisions across C-Level, marketing, R&D, clinical, regulatory and commercial department right from product development, product launch and post marketing support. Our team has decades of experience and insights to global markets in planning and commercializing pharmaceutical, med-tech, cosmetic and nutrition products.
Our comprehensive market intelligence approach covers all key areas of life-sciences products to enable critical commercial decisions.
Branding & Product Launch
Artixio's branding team includes seasoned professionals who have helped Fortune 500 companies launch their consumer brands in global markets. Understanding consumer insights and translating them into an integrated brand strategy including a visual design, communication plan and Public Relation strategy for product launch is key to Artixio's offering.
Our creative partners, TwoDo, are a Cannes Young Lions award winning team that create magic with brands, every time!
If you are planning to develop and commercialize a cosmetic, food/nutrition, pharmaceutical or medtech product, our patient/user centric approach enables us to be your one stop partner from patient/user research, market strategy, brand personality development, visual branding, copy writing/medical writing and communication strategy including digital, print and other media communication.
