ADVANCING CLINICAL RESEARCH

Bridging the Gap Between Science and
People.|

Our Services

Comprehensive Clinical Development Support

Expert guidance and support across the entire drug development lifecycle

Pharmaceuticals & Biologics Consulting

Former FDA regulatory expertise for your drug development journey.

Device Consulting

A specialized device team awaits your next innovation.

Support Services

Helping you meet your functional and operational needs.

Business Units

One team. Multiple business units. Every step of the way.

Have Questions?

Frequently Asked Questions

Find detailed answers to common questions about our consulting services, expertise, and how we can help your business succeed.

What is the background and experience level of your consultants?

Our consultants are industry veterans with extensive experience in pharmaceutical and biotech development. Most have held senior positions within regulatory agencies or leading biopharmaceutical companies, bringing decades of hands-on expertise in drug development, regulatory affairs, and clinical research.

What's the process for getting a project started?

Getting started is simple. Contact us through our online form to discuss your needs. We'll assess your requirements, assign a dedicated team lead, and provide a detailed project proposal outlining our approach, timeline, and deliverables.

Do you provide regulatory support for international submissions?

Yes, we provide comprehensive regulatory support for both U.S. and international submissions. Our team has experience with FDA, EMA, and other regulatory bodies, ensuring your submissions meet all necessary requirements across different jurisdictions.

Can you provide insight into pre-IND and IND submission expectations and timelines?

Yes, we have extensive experience with scheduling and preparing for pre-IND meetings and IND submissions. Our team can guide you through the process, timeline expectations, and requirements.

Can you assist with clinical trial design and development plans?

Yes, we offer comprehensive clinical trial services designed to ensure successful study outcomes. From designing and overseeing a clinical trial program to serving as an in-house expert, our team assists throughout all phases of clinical development.

Can you help with FDA clinical holds or review responses?

Yes, our clinical consultants are experts at interpreting and responding to FDA's comments, including addressing clinical holds and other regulatory feedback.

Do you offer Quality System and auditing services?

Yes, we have consultants experienced in preparing Quality System documentation, conducting mock audits, and providing input on post-market strategies, including compliance reporting and recalls.

How do you ensure compliance with GMP requirements?

Our team includes GMP experts who can help establish and maintain compliant manufacturing processes. We provide guidance on facility design, process validation, and quality control systems to meet current GMP standards.

What experience do you have with regulatory inspections?

Our consultants have extensive experience with FDA, EMA, and other regulatory agency inspections. We can help prepare for inspections, provide mock audits, and assist with responding to inspection findings.