Expert Advisory Services

Going beyond the test: We help our clients at every phase of the product development life cycle.

Nelson Labs Risk Assessment Technical Consulting Experts

Value-added advisory approach

Nelson Labs Expert Advisory Services offers a wide breadth of MedTech and pharmaceutical experience to help our clients deliver safe and effective products to market. Our Expert Advisory Service encompasses product development, facility and process validation, and product performance testing, as well as regulatory support.

Each expert advisor brings a unique perspective based on years of industry, regulatory, and scientific expertise. By participating in industry groups, actively working on the standards committees (AAMI/ISO/ASTM/PDA), and partnering with a broad range of MedTech and pharma companies on many product types, our experts bring a breadth of experience to each relationship. Although our lab processes over 50,000 projects each year, our expert advisors ensure success for our clients one project at a time.

By focusing on what matters most, we help our clients deliver life-saving products with every test through our value-added advisory approach.

Download Our Expert Advisory Services Brochure

Click Here to Meet Our Experts

What We Do

Discovery Team

Observation and onsite review of client processes, quality management systems, validation files, and product development phase gates
Assessment and needs discovery related to product development to support validation for regulatory compliance and product submissions
Collaborative development of process changes and tailored solutions for continuous product improvement

Education

Onsite and client-specific training related to industry best practices, current regulatory, and test guidance
Custom webinars for client training, regulatory updates, and product-specific case studies

Expert Advisory Service

Product design file review and design phase input
Facility validations (water systems, environmental, and process controls)
Regulatory support for submissions, product changes, detentions, or rejection notices
Test plans, protocols, and written justifications for method selection

Why Choose Us?

Proven Experience

Experience with successful validation and regulatory approvals across thousands of product types in multiple MedTech industry segments (medical device, pharmaceutical, tissue).

Industry Involvement

We remain up-to-date by actively participating on the standards committees and working with industry and regulatory groups to shape the future of MedTech and pharma standards (AAMI/ISO/ASTM/PDA).

Thought Leadership

Each of our foremost expert advisors contributes to industry education through publications, seminars, webinars, and hosted events. By combining their laboratory, regulatory, and manufacturing experience and insights, they give clients a full perspective on critical topics and changes.

See Our Influence in Action

Global Code of Conduct

Our entire Nelson Labs team is committed to offering impartial,
unbiased advice to clients to maintain the integrity of the services
we offer.

Read Our Global Code of Conduct