Biologic Regulatory Affairs

Tailored and compliant solutions from credible experts.

Streamlining your program from early development to commercial, we deliver regulatory guidance and packages tailored to you and your molecule.

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Ensuring compliance and a robust regulatory strategy, we develop phase-appropriate qualification, characterization, and analytical method validation strategies appropriate to your stage of product development and assist in the preparation of global filings.

Phase appropriate validation

We offer consolidated phase-appropriate validation packages with fit-for-purpose methods and robust de novo assays that stand up to regulatory scrutiny.

Ensuring conformance with ICHQ2(R2), our scientists ensure cGMP compliance and the highest levels of efficiency without compromising product quality or patient safety.

Based on our decades of regulatory experience, we will provide the best strategy for your molecule, regardless of its phase. We are here to support all your regulatory needs.

Process characterization

Ensuring the robustness and repeatability of your process and consistent quality of product, we utilize design of experiment (DOE) studies to ensure your process is fully understood and documented to support successful regulatory submissions.

Saving time and ensuring scalability, we are committed to quality excellence and designing and delivering tailored solutions with patient safety in mind.

Our team has expansive experience and capability to consider your process requirements prospectively, developing a series of protocols and regulatory strategies tailored to your molecule and desired function.

Analytical methods

Helping you meet regulatory and quality requirements, our experts provide guidance and design; execute; and document analytical method development, qualification, and validation programs to support even your most complex molecules.

Ensuring Compliance Throughout

We follow ICHQ2(R2) guidelines for method validation, delivering robust programs that meet your requirements.

Adaptable to your needs and standards, our expert analytical teams are fully integrated into your project, giving you access to data quickly.

Collaboration between our analytical, and process and formulation teams ensure the development and validation of robust phase-appropriate methods.

Partner with us

We are committed to achieving quality excellence. We’re transparent in our communications and work collaboratively to progress your programs.

Our team works with you and uses deep scientific and technical know-how to find the best solutions using the right technologies to deliver your program with a constant commitment to quality.

We adapt our approach, shorten the lead times, and develop risk mitigation strategies to ensure your overall success to get vital medicines to patients.