etra

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.

Etra Intelligence

Automation Services for Life Sciences

Streamlining clinical trials and manufacturing with cutting-edge automation.

Principal Investigators (PIs)

Automate data collection, patient monitoring, and reporting in your clinical trials. Reduce administrative burden and focus on research with our custom automation solutions.

CDMOs

Enhance your manufacturing efficiency and quality control with automated process control, batch records, and supply chain management. Ensure compliance and scalability.

Biotech Companies

Accelerate your R&D and production timelines with automated lab workflows, data analysis pipelines, and quality assurance processes. From discovery to market, we support your journey.

Our Expertise

Clinical Trial Automation

We provide solutions for automating patient recruitment, data management, and regulatory submissions. Our tools integrate seamlessly with existing clinical trial management systems (CTMS).

Manufacturing Facility Automation

From process analytical technology (PAT) to fully automated manufacturing lines, we help you build smart facilities that are compliant with cGMP standards and ready for Industry 4.0.

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.

Can you review Critical Quality Attributes (CQAs) and analytical methods?

Yes, our consultants can provide expert review of quality data from an FDA perspective and identify potential issues that need to be addressed before submission.

Do you provide Quality Training and method validation support?

Yes, we develop and host customized Quality Training sessions and can help with method development and validation, either on-site or remotely.

Do you have experience with FDA device submissions?

Yes, our team has extensive experience preparing all types of FDA medical device submissions, including 510(k)s, PMAs, IDEs, and de novo applications. Our experience from both industry and regulatory perspectives helps ensure submissions meet FDA expectations.

What types of medical devices do you work with?

We have experience across a broad range of medical devices, including cardiology, surgical devices, in vitro diagnostics, drug delivery devices, software-based devices, and combination products.

Do you assist with FDA meetings for device submissions?

Yes, we frequently serve as FDA contact persons and attend meetings on behalf of clients. Our familiarity with the FDA process helps navigate and prepare for critical meetings throughout device development.

Contact Etra Therapeutics

We are excited to hear from you. Let's see if your clinical needs and our capabilities are a good match.

Get In Touch

We'd love to hear from you. Send us a message and we'll respond as soon as possible.

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Bridging the Gap Between Science and People.|