Customized Services
Strategies Tailored to Achieve Your Goals
Whether you're just starting your development program and need to craft your regulatory strategy, are preparing for discussions with regulatory agencies to file your IND/CTA, are advancing into pivotal clinical studies, or are gearing up to submit a marketing application, we're here to assist every step of the way.
We assist you in developing the optimal regulatory roadmap based on your unique requirements and needs, considering your specific development goals, corporate milestones, budget, tolerance for risk, and available data.
Customized Services
Regulatory Strategy and Development
Assistance in crafting a comprehensive regulatory strategy customized to your product and providing a roadmap to guide you through the regulatory landscape.
Orphan Drug Designation
We support clients in developing drugs or biological products to prevent, diagnose, or treat a rare disease or condition by facilitating the orphan drug designation (ODD) process.
Expedited Program Designations
Guidance on selecting the most suitable expedited program for your product and offering assistance in evaluating your product as well as navigating the designation process.
Labeling and Target Product Profile
We are knowledgeable about the most recent regulations for labeling and best practices to develop target product profiles and can help you identify what will work best for your product.
Health Authority Meetings
Serving as your representative when meeting with health authorities, accompanying you through all stages from planning to interactions with the agency,
Marketing Applications
We help our clients navigate, develop, and defend marketing applications, including New Drug Applications (NDAs), Biologics License Applications (BLAs), and Marketing Authorization Applications (MAA).
IND and CTA
We work closely with our clients to implement the most appropriate strategy for achieving approval from the US FDA and other regulatory authorities.
US Agent Services
We facilitate FDA communication for our non-US clients, serving as the intermediary. Recognized by the FDA as equivalent to the sponsor, we manage document reception and promptly address urgent inquiries, ensuring effective and seamless interaction.