What We Bring to Every Engagement
We've worked inside big pharma, built a CRO/CDMO from the ground up, and guided programs across the US, Europe, Canada, Australia, and beyond. We see the whole program because we've lived every part of it.
End-to-End Experience
From pre-clinical through post-approval, in the lab and in leadership.
International Regulatory Fluency
Submissions accepted across the US, EU, Canada, Australia, and the UK.
Cross-Functional Coordination
Bridging science, manufacturing,
regulatory, and program teams.
Strategic & Scientific
Senior leadership perspective grounded in hands-on technical
expertise.
How We Work With You
Every engagement is different. We work where your program needs us most, from early- stage strategy through post-approval support, bringing the same senior expertise and dedicated focus to every stage.
1 - CMC STRATEGY & PLANNING
From first molecule to clinical readiness, we develop phase-appropriate CMC strategies that align with your regulatory pathway and program goals. This includes formulation development, analytical method development and validation, specification setting, stability programs, tech transfer support, and Quality by Design (QbD), built around where your program is today and where it needs to go.
2 - PROGRAM MANAGEMENT
Our approach to program management goes beyond tracking milestones. We bring cross-functional coordination and integrated development planning that keeps complex programs moving, managing timelines, budgets, vendors, and the people in between with the same care we'd bring as a full-time team member.
3 - REGULATORY INTELLIGENCE
Navigating FDA guidance, ICH guidelines, and international regulatory requirements takes experience. We provide regulatory gap analyses, submission planning, and dossier preparation for IND, CTA, IMPD, NDA, BLA, and MAA filings, and support agency interactions, such as pre-IND meetings.
4 - QUALITY & COMPLIANCE
From GMP readiness assessments and supplier qualification to change control strategy, we help clients build quality systems that hold up under scrutiny and scale as the program grows.
5 - LIFECYCLE STRATEGY & MANAGEMENT
Most consultants focus on getting to approval. Our experience doesn't stop there. With a background that spans pre-clinical through post-submission, both in the lab and in oversight, we bring a strategic view to post-approval changes, comparability assessments, and long-term regulatory commitments that protects what you've built.
6 - GLOBAL & INTERNATIONAL CMC STRATEGY
For programs with international ambitions, we offer regulatory guidance across multiple markets including the US, EU, Canada, Australia, and the UK, with growing expertise in emerging markets. We can assess clinical trial feasibility by country, prepare CMC sections for international submissions, and help navigate the unique requirements of programs developed for low- and middle-income countries.
7 - SCALE-UP & MANUFACTURING READINESS
When it's time to move from lab to clinic to commercial scale, we draw on a strong network of trusted manufacturing partners and subcontractors to support process scalability assessments, pilot and commercial manufacturing, and supply chain planning, bringing oversight and strategic coordination at every step.
Designed for Your Product
We bring hands-on experience across molecule types, dosage forms, and development stages, so you're never starting from scratch with someone who has to learn your science before they can help you.
Peptides | Small Molecules | Proteins
Oral: Solutions, Suspensions, Capsules, Tablets, Sachets
Topical: Gels, Creams, Emulsions, Microneedles
Parenteral: Solutions, Suspensions
Ophthalmic: Solutions, Suspensions
Drug-Device: Pre-filled Syringes
Pre-clinical through post-approval, in the lab and in oversight.
About Lisa Crandall, Founder and Principal
Lisa brings more than 25 years of hands-on pharmaceutical experience spanning the full journey of drug development from pre-clinical formulation and analytical method development to clinical manufacturing, regulatory submissions, and post-approval lifecycle management. She began her career at Parke-Davis and Pfizer before joining Velesco Pharma as its first employee, where she spent 16 years building and leading a team that grew alongside some of the most complex programs in the industry, including a decade-long project that resulted in an approved treatment for Duchenne muscular dystrophy. That combination of science and senior leadership, knowing both how the work gets done and how to drive it strategically, is rare in consulting and central to how she works with clients.
Lisa holds a B.S. in Biochemistry from the University of Michigan, an M.S. in Pharmaceutical Sciences from the University of Nebraska Medical Center, and Graduate Certificates in International Biopharmaceutical Regulatory Affairs from Northeastern University and Biotech Project Management. Her regulatory experience spans submissions accepted in the US, Europe, Canada, Australia, and the UK, and she is equally fluent in the science behind the strategy.
Beyond her consulting practice, Lisa has spent more than a decade partnering with the University of Utah's Moran Eye Center and EyeCorps on ophthalmic surgical outreach in Nepal, Ghana, Tanzania, and the Navajo Nation. This work informs her deep interest in global health access and international regulatory pathways, which she is actively working to formalize as part of her practice.
25+ years in pharmaceutical development and regulatory affairs
Experience across small biotech to large pharma environments
Proven track record of successful regulatory submissions
WHAT CLIENTS SAY
WHAT CLIENTS SAY
"I am pleased to recommend Lisa Crandall as a consultant in the area of formulation support. In the time working with Lisa on our Vamorolone Duchenne Pediatric Rare Disease project, first approved by the FDA in 2023, Lisa demonstrated scientific ability and rigorous analytical thinking. She led drug product analytical and formulation development, designed and executed the required studies that supported animal and human work, and developed practical solutions that directly advanced the program. The clinical formulation, an orange flavored suspension, was modified only slightly for commercial use. Her technical leadership was important during early regulatory submissions and in resolving post‑submission issues, ensuring the product met quality and safety expectations. I strongly endorse Lisa for the support of preclinical and clinical formulation work. She’s good."
John McCall, Chemistry Consultant and Board Chair Reveragen BioPharma Inc.
WHAT CLIENTS SAY
Ready to Move Your Program Forward?
Whether you need CMC strategy, regulatory guidance, or a dedicated partner for the full journey, we're ready to connect. Or do you just need some quick help?