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The FDA has launched Project Optimus for oncology drug products
Our goal is to make your drug development time-efficient and cost-effective, driving successful outcomes or identifying pitfalls early. We will assist you in fortifying your Clinical Development Plan (CDP) with strategic planning for ultimate drug approval, backed by solid CMC regulatory support.
Our goal is to make your drug development time-efficient and cost-effective, driving successful outcomes or identifying pitfalls early. We will assist you in fortifying your Clinical Development Plan (CDP) with strategic planning for ultimate drug approval, backed by solid CMC regulatory support.
Through Model-Informed Drug Development (MIDD) using PK, PKPD, and exposure-response relationships for efficacy and safety, we will explore the best options to address regulatory questions.
Through Model-Informed Drug Development (MIDD) using PK, PKPD, and exposure-response relationships for efficacy and safety, we will explore the best options to address regulatory questions.
When looking for the best solutions, AreteVolo is your partner.
When looking for the best solutions, AreteVolo is your partner.
Regulatory Strategy
Regulatory Strategy
Ultimate goal of drug development is to obtain marketing authorization in the target territory. To achieve such goals, AreteVolo will guide you step-by-step with feasible options.
Regulatory Meetings
Regulatory Meetings
During drug development, seeking advice and reaching agreement with regulatory agencies are critical for your ultimate success. AreteVolo will assist you to prepare meeting packages for successful outcomes.
Clinical Pharmacology
Clinical Pharmacology
AreteVolo has a proven track record of success in applying PK and PKPD to drug development. We are experts in utilizing these surrogate markers as indispensable tools for decision making.
Model-Informed Drug Development
Model-Informed Drug Development
AreteVolo offers comprehensive elements for MIDD to help you succeed in efficient drug development at every stage. It is well known that MIDD is extremely important for time/cost effective drug development.
Regulatory CMC
Regulatory CMC
AreteVolo has up-to-date expertise and offers professional guidance to help you achieve regulatory success. We can help you develop an adequate CMC regulatory strategy for your drug development program.
Clinical Data Management
Clinical Data Management
AreteVolo's data programming tool allows you to prepare standardized data for regulatory submission. Standardized data may also be utilized as effective sources of automation tools.
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