Thera Biotech — Fractional Chief Quality & Regulatory Officer

01 / The Gap

You've built the science. Who owns getting it approved — and keeping it compliant?

Most growing biotech, pharmaceutical, and natural-health companies hit the same wall.

The product is real, the team is strong — but there's no senior quality or regulatory leader on staff, and a full-time Chief or VP costs more than the stage can justify.

Submissions stall. Audits loom. Investors and partners start asking who's accountable for compliance — and no one has a confident answer.

Thera Biotech gives you that person, fractionally: owning your FDA and Health Canada strategy, building quality systems that pass inspection, and representing you to regulators — at a fraction of the cost of a full-time hire.

02 / Who It's For

Built for companies with a real product and a missing seat on the org chart.

A clinical-stage or commercial biotech without a full-time quality or regulatory leader.

A natural-health or supplement company facing FDA or Health Canada requirements — GRAS, NDI, cGMP licensing.

A founder preparing a submission, audit, or partnership and needing credible senior sign-off.

An investor or board wanting regulatory and CMC due diligence before committing capital.

03 / Services

Three ways to work together.

One flagship engagement, a project track for defined needs, and a low-commitment front door to start.

Flagship

Fractional Chief Quality & Regulatory Officer

A monthly retainer where Navneet acts as your part-time senior quality and regulatory leader — embedded in your team, accountable for the outcome.

Owns your QMS and cGMP posture
Sits in leadership meetings & reports to the board
Represents you to the FDA, Health Canada & partners
Mentors and builds your internal team

Projects

FDA & Health Canada Advisory

Defined, fixed-scope engagements when you need a specific outcome rather than an ongoing officer.

Regulatory pathway strategy
Pre-IND & meeting preparation
GRAS determinations & dossiers
CMC strategy & gap assessments
Regulatory due diligence for investors

Start here

FDA Readiness Assessment

A senior-level review of your regulatory pathway, quality systems, and submission readiness — delivered in 2–3 weeks.

Board-ready readiness report
Prioritized risk register
90-day action roadmap
Live strategy debrief
Fee credited toward your next engagement

04 / How It Works

Senior judgment, sized to your stage.

Readiness Assessment

We map where you are and exactly what US or Canadian compliance and approval require.

Right-sized engagement

A fractional CQRO retainer for ongoing leadership, or a defined advisory project for a specific outcome.

Embedded execution

Navneet works inside your team — in your meetings, on your submissions, representing you to regulators.

Capability that stays

A decade of graduate teaching means he leaves your team stronger, not dependent.

05 / Why Navneet

Few advisors speak the language of the scientist, the regulator, and the investor. He speaks all three.

Bench-to-boardroom, in one advisor

He built the processes, led the quality function, and earned the business credential — so you don't need three different consultants.

Real FDA experience, not theory

Submissions, GRAS, and quality compliance delivered at the executive level — not just described.

He reads the science

Two decades developing fermentation and purification processes means he understands your CMC data, not just your paperwork.

A teacher at heart

A decade of graduate teaching means he doesn't just fix the problem — he leaves your team able to handle the next one.

vs. a full-time hire

Chief-level experience now, at a fraction of the cost — no long ramp, no equity-heavy commitment before you're ready.

vs. a CRO or junior consultant

Senior expertise direct from the person doing the work — accountable, hands-on, and invested in your outcome. Not a faceless vendor handing your project to juniors and walking away when the invoice clears.

06 / About

Navneet Sharma, PhD, EMBA

Navneet Sharma

PhD, EMBA · Founder & Principal Advisor

— PhD, Molecular Biology & Biochemistry

— EMBA, Innovative Leadership

— ex-Chief of Quality & Regulatory, IGY Life Sciences

— ex-DSM Anti-Infectives · HTC Extraction Systems

— Adjunct Asst. Professor, U Calgary Faculty of Medicine

— Published in PLOS One, Vaccine, Biological Chemistry

— US & Canadian patent applications

More than two decades across pharma, biotech, and academia — pointed at one purpose: getting your product to market and keeping it compliant.

As Chief of Quality & Regulatory Compliance at IGY Life Sciences, Navneet led quality and regulatory strategy including FDA engagement, GRAS designation, and cGMP licensing. Earlier — at DSM Anti-Infectives, HTC Extraction Systems, and the University of Calgary — he developed fermentation and purification processes for semi-synthetic antibiotics, recombinant enzymes, antibodies, and vaccines, and built deep expertise in high-throughput proteomics, spanning R&D, process development, regulatory affairs, and quality assurance.

He served as Adjunct Assistant Professor in the Faculty of Medicine at the University of Calgary, teaching biotech business, quality, and regulatory affairs at the graduate level for over a decade. His research produced publications in journals including PLOS One, Vaccine, and Biological Chemistry, contributions to the Handbook of Proteolytic Enzymes, and US and Canadian patent applications.

His PhD gives him command of the science; his EMBA in Innovative Leadership lets him sit with a board. That range — bench, regulator, boardroom — is what companies trust him with on the path from discovery to approval.

07 / Selected Publications

Two decades of peer-reviewed science behind the regulatory judgment.

From fermentation and recombinant protein purification to vaccines, antibodies, and human clinical trials — published across three decades.

2026

Nutrients

Muno-IgY supplementation improves respiratory health, immune response, and exercise-induced physiological stress in healthy adults: a randomized controlled pilot study

Fathima S, Kilgore PE, Sarkar T, Sharma N, Nguyen HH · Nutrients 2026;18(3):524 — a Health Canada–authorized randomized clinical trial

2026

Microbiome Research Reports

Immunoglobulin Y protects intestinal epithelium and modulates gut microbiota

Fathima S, Sarkar T, Sharma N, Kilgore PE, Nguyen HH · Microbiome Res Rep 2026;5:8

2015

Journal of Molecular Biology

Bacteriophage display of peptides and its use in determining proteolytic substrate specificity

Liu C, Nahal J, Melton K, Sharma N · J Mol Biol 2015

2011

Vaccine

Peptide vaccination is superior to genetic vaccination using a recombineered bacteriophage λ subunit vaccine

Thomas BS, Nishikawa SG, Ito K, Chopra P, Sharma N, Evans DH, Tyrrell DLJ, Bathe O, Rancourt DE · Vaccine 2011;30(6):998–1008

2011

PLOS One

Implantation serine proteinase 1 exhibits mixed substrate specificity that silences signaling via proteinase-activated receptorsFirst author

Sharma N, Kumar R, Renaux B, Saifeddine M, et al. · PLoS One 2011;6(11):e27888 — recombinant expression in Pichia pastoris and multi-step purification

2008

Biological Chemistry

Substrate specificity determination of mouse implantation serine proteinase and human kallikrein-related peptidase 6 by phage displayFirst author

Sharma N, Oikonomopoulou K, Ito K, Renaux B, et al. · Biol Chem 2008;389(8):1097–1105

1992

Enzyme and Microbial Technology

Influence of dilution rate and dissolved oxygen concentration on continuous keto acid production by Gluconobacter oxydans subsp. melanogenum

Buse R, Onken U, Qazi GN, Sharma N, Parshad R, Verma V · Enzyme Microb Technol 1992;14(12):1001–1006 — continuous fermentation & bioprocess scale-up

Selected from a body of work spanning molecular biology, proteomics, and bioprocess development, alongside US and Canadian patent applications.

08 / Advisory Network

Senior depth, on call when a project needs it.

Beyond Navneet, Thera Biotech draws on a network of senior specialists in clinical and non-clinical development, bioprocessing, and trials.

Dr. Allen W. Davidoff

Drug Development · Clinical & Regulatory

President & CEO of XORTX Pharma; co-founder of Stem Cell Therapeutics. 14+ years advancing small-molecule and biologic programs through IND, multiple Phase I–II trials, and an NDA across six countries.

Dr. Derrick Rancourt

Bioprocessing · Cell Therapy

Professor at the University of Calgary and Director of its Centre for Mouse Genomics. Expertise in pluripotent stem-cell bioprocessing and scalable bioreactor process development.

Dr. Rachel Syme

Clinical Trials · Research Administration

Assistant Director with CIHR's Institute of Cancer Research. Deep experience in clinical-trials operations, administration, and research ethics across major Canadian institutions.

The Front Door

Know exactly what stands between your product and the market — in three weeks.

A senior-level review of your regulatory pathway, quality systems, and submission readiness for the US FDA and Health Canada — led personally by Navneet. You walk away with a clear, prioritized picture you can put in front of your board.

FDA Readiness Assessment

Fixed fee · Fixed timeline · 2–3 weeks

Written, board-ready readiness report
Prioritized risk register (critical / high / medium)
Recommended regulatory pathway
90-day action roadmap
90-minute live strategy debrief

Book your assessment →

Move forward within 60 days and your assessment fee is credited toward your first engagement.

A Chief Quality & Regulatory Officer — without the full-time hire.

You've built the science. Who owns getting it approved — and keeping it compliant?

Built for companies with a real product and a missing seat on the org chart.

Three ways to work together.

Fractional Chief Quality & Regulatory Officer

FDA & Health Canada Advisory

FDA Readiness Assessment

Senior judgment, sized to your stage.

Readiness Assessment

Right-sized engagement

Embedded execution

Capability that stays

Few advisors speak the language of the scientist, the regulator, and the investor. He speaks all three.

Bench-to-boardroom, in one advisor

Real FDA experience, not theory

He reads the science

A teacher at heart

Navneet Sharma, PhD, EMBA

Navneet Sharma

Two decades of peer-reviewed science behind the regulatory judgment.

Senior depth, on call when a project needs it.

Dr. Allen W. Davidoff

Dr. Derrick Rancourt

Dr. Rachel Syme

Know exactly what stands between your product and the market — in three weeks.

Find out exactly what stands between your product and the market.