The Regulatory Landscape
The life sciences industry is a complex and highly regulated landscape. Bringing a new product or medical device to market requires navigating a labyrinth of regulations, from pre-clinical studies to manufacturing and post-market surveillance. This is where we come in.
We work with clients to define or streamline systems and processes ensuring regulatory compliance in the most efficient way possible. Helping emerging life science companies define and implement a regulatory framework that ensures compliance with US and international regulations with minimal resources. Effectively streamlining the framework systems to minimize the friction of going to market while identifying, prioritizing and implementing solutions or proving alternatives as necessary.
The Person Behind
the Work
Scott Hatlestad has spent more than two decades navigating the intersection of quality systems, regulatory frameworks, and the real-world constraints of emerging life science companies. When you hire Hatlestad Consulting, you get Scott — not a project manager who will hand your work off.
His background spans CSV and CSA for clinical and manufacturing systems, data integrity governance, 21 CFR Part 11 and Annex 11 compliance, and electronic clinical trial system implementation across eTMF, EDC, IRT, and CTMS platforms. He has supported companies ranging from early-stage biotechs building their first quality system to established pharma organizations preparing for FDA inspections — and his work has appeared in the evidence packages of multiple successful ones.
Scott brings a pragmatic, risk-based approach that treats compliance as an enabler of speed to market, not a tax on it. He's known by senior QA and IT leaders at client companies for the ability to wear multiple hats — supporting Quality, IT, Finance, and Operations — while consistently delivering high-quality work product on demanding timelines.
Our Core Attributes
Proficient
Embodying deep, practical knowledge combined with streamlined approaches to navigate the complexities of life science regulations and quality assurance. We don't just understand the regulations, we translate it into clear, actionable solutions that empower your business to thrive.
Personalized
We tailor our regulatory compliance and quality assurance solutions to the unique needs and challenges of each life science client, exceeding industry standards with laser-focused expertise and unwavering guidance.
Thorough
Unwavering scrutiny represents our relentless commitment to detail. We leave no stone unturned in our pursuit of regulatory compliance and quality assurance, applying deep expertise and comprehensive methodologies to meticulously analyze every aspect of your life science operations. This uncompromising thoroughness is the bedrock of our service and the foundation of your success.
Collaborative
We believe compliance excellence isn't achieved alone. Bridging expertise signifies our commitment to combining our deep regulatory knowledge with your unique company context and challenges. Building compliance together underscores our collaborative approach, where we partner with you, not just advise you, to navigate the regulatory landscape and build a robust quality assurance system.
Our Partnership Philosophy
We believe that compliance is not a destination, but a continuous journey of improvement and innovation. We partner with you, shoulder-to-shoulder, mind-to-mind, to build robust quality systems that are not just compliant, but inherently great. We are here to work together in developing trust-worthy validated systems and processes that scale with your growth and brand framework.
I have worked with Scott for close to ten years... his interpersonal skills make him a very valuable and versatile asset to an organization... He always delivers high quality work products; team members know they will be successful with Scott as a team member.
Beth C.
Vice President IT / CIO
Commercial-stage drug-delivery technology biotech