Services Clinical Development Early Stage

Regulatory Solutions

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Powering Excellence with Regulatory Intelligence

Our Regulatory Team at Accelsiors not only brings vast experience and expertise to the table but also supports our clients throughout the lifecycle of a clinical trial. We take it upon ourselves to ensure all your regulatory objectives are met within the stipulated timelines.

Guiding you through the maze of regulations is our mission. We strategize and plan the best routes to help you meet your corporate objectives. What’s more, we excel at outlining and supporting the most efficient pathway for your development process and clinical trial applications.

As a global entity with offices and personnel around the world, Accelsiors keeps abreast of evolving country-specific regulatory requirements. Our centralized Regulatory Affairs unit is reinforced by local regulatory specialists, which guarantees quality, consistency, and adherence to national/international regulations, directives, and laws.

We at Accelsiors recognize the significance of:

  • Timely Execution: Thanks to our close-knit project team, we set and achieve regulatory timelines with precision.
  • Compliance: Our experienced regional and local regulatory representatives ensure conformity with both international and local regulatory requirements.
  • Quality Deliverables: Even under pressure and tight deadlines, we prioritize quality, ensuring that every deliverable meets our high standards.
StrongCORE Scientific
We are a truly scientifically and quality-driven CRO. We do not only monitor a study, but we ensure that our subject matter experts are optimally driving the study from design to execution.

Allow us to maximize the value of your clinical development program. We will ensure that your study is performed based on the scientific understanding, medical knowledge, regulatory compliance, and experience of our team.

StrongCORE Scientific - Knowledge, experience, compliance
Crafting Tailored Regulatory Management Plans for Success

At Accelsiors, we understand the essential role a Regulatory Management Plan (RMP) plays in every study. Working in close collaboration with our sponsors, we created a comprehensive RMP that outlines the complete regulatory strategy for the trial.

We take pride in our prowess at defining and supporting the most efficient routes for the development process and marketing applications. Our commitment to consistent compliance with international and local regulatory requirements is unwavering. This is made possible by our seasoned regional and local regulatory representatives and our relentless focus on delivering high-quality outcomes.

In response to the recent COVID-19 pandemic, global authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued guidelines for managing new and ongoing clinical trials. Keeping abreast of these developments, Accelsiors is actively monitoring regulatory updates and gathering pertinent information from regulatory authorities. Our aim is to provide our clients with pragmatic advice to help their projects continue without a hitch.

During these challenging times, Accelsiors stands by you, offering the flexibility and support you need to succeed in your projects.

Let us accelerate your clinical drug development program!