Suite Life Sciences Consulting partners with biotech and specialty pharma to build regulatory strategy, run FDA submissions, and stand up the systems and teams that carry a program from IND to approval — on a fractional, interim, or project basis.
Whether you need a hands-on leader for a critical submission or a steady regulatory voice in the room, engagements flex to the stage and scale of your company.
Fractional or interim head of regulatory for small-to-mid-size companies — building the strategy, the roadmap, and the team to execute it.
INDs, NDAs, 505(b)(2) applications, orphan drug and pediatric filings, and sNDAs — plus the meeting strategy behind Type A–D interactions and End-of-Phase 2.
Promotional review governance, launch-readiness, and the escalation processes that keep commercial claims compliant without stalling the business.
EMA, MHRA, BfArM, TGA and Health Canada strategy — and coordinating ex-US filings through regional partners and marketing collaborators.
Independent regulatory assessment for financing, licensing, and corporate development — surfacing the risks and inflection points that drive valuation.
Selecting and standing up label management, EDMS, and RIM/publishing capabilities — building regulatory infrastructure ahead of growth, not behind it.
Suite Life Sciences Consulting is the practice of Mark Charest, MS, RAC — a regulatory affairs executive with more than 25 years across biotech and specialty pharma, from rare disease and GI to pain and specialty products.
As a VP of Regulatory Affairs and, in earlier roles, the US and Global Regulatory Lead serving as the primary FDA point of contact, Mark has run 20+ FDA meetings, built submission and label-management systems, secured pediatric exclusivity worth roughly $100M, and led regulatory strategy through financings and corporate development.
The through-line is a roll-up-your-sleeves operator who builds regulatory capability sized to the company in front of him — pragmatic, honest about risk, and focused on keeping programs moving.
Engagements available through Suite Life Sciences Consulting, LLC on a 1099 or Corp-to-Corp basis.
Two-and-a-half decades of regulatory work concentrated where small and mid-size companies feel the most pressure.
Rare disease, GI, pain & specialty, drug-device combination products, and CNS-adjacent programs.
IND, NDA, 505(b)(2), sNDA, orphan drug & pediatric exclusivity, CTAs, and eCTD strategy.
Pre-IND through Type A–D meetings, End-of-Phase 2, Advisory Committees, and Emerging Technology programs.
Standing up regulatory teams, promotional review governance, and label / document management systems.
Most engagements start at one of these moments. If one of them describes where you are, the conversation is probably worth having.
A vacancy at the top of regulatory stalls submissions, agency correspondence, and decisions that cannot wait for a search to conclude.
Pre-IND, End-of-Phase 2, Type B or C. The briefing package and the questions you ask determine what the Agency lets you do next.
The work is cross-functional, the timeline is fixed, and it needs someone who has run one end to end before.
Processes, SOPs, submission planning, and document and label management that were adequate at Phase 1 are not adequate at Phase 3.
A steady regulatory voice in development and leadership discussions, sized to what the company actually needs right now.
Independent regulatory diligence that surfaces the risks and inflection points before the term sheet, not after.
Straightforward, low-friction, and built around your program's timeline — not a long onboarding.
A short working session to understand the program, the regulatory questions in front of you, and where an outside leader adds the most value.
A defined engagement — fractional leadership, an interim seat, or a specific submission or due-diligence project — with clear deliverables and cadence.
Hands-on execution and a clear paper trail, so the strategy, submissions, and systems outlast the engagement.
Whether it's a submission on a deadline, a function that needs building, or a program that needs a seasoned regulatory voice — let's talk.