SERVICES TO BE PROVIDED

• ·         Evaluation of regulatory options focused on international requirements
• ·         Discussion and review of development strategies and business plans
• ·         Interaction with regulatory agencies e.g. USA and Europe
• ·         Regulatory support to biotech companies and other pharmaceutical companies
• ·         Clinical development plans
• ·         Input to and review of CMC documentation
• ·         Regulatory strategies
• ·         Preparation of regulatory documents
• ·         Preparation and conduct of meetings with regulatory agencies
• ·         Regulatory due diligence
• ·         Preparation of INDs and CTAs
• ·         Assist, advise and prepare applications for Orphan Drug Designations
• ·         Marketing applications
• ·         Training
• ·         Project management

CUSTOMER BENEFIT

• Reduced time to market
• Cost-effective development
• Optimized return on investment
• Increased credibility of the company with partners and investors
• International requirements and business needs included in development plans and documentation
• Ensure the best product labelling and competitive positioning
• The right documentation in the correct format at the right time

Working with you in close cooperation, DTA Consulting will provide recommendations on how to obtain these benefits. By knowing the regulatory requirements and pathways you will be able to focus on optimized development of your products.

Brydegaardsvej 25, DK2760 Maalov. Tel.: +45 29656927
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