Services Built for Translational Reality
Integrated R&D, regulatory & quality, clinical, and market strategy designed to reduce risk, improve decision-making, and accelerate patient impact.
R&D / Preclinical
We guide early and mid-stage development with a translational lens — ensuring technical decisions align with regulatory expectations, clinical feasibility, and downstream commercialization.
- • Assist with creation of user needs user & targets product profile (TPP)
- • Design input & development oversight
- • Cost- and time-efficient testing strategies
- • Design of full biological testing portfolio
- • Protocols and execution - from feasibility, pilot, to GLP
- • Experts in custom ISO 10993
Regulatory & Quality
Regulatory and quality considerations are embedded early — not layered on after development decisions have already been made.
- • Global regulatory pathway strategy
- • FDA & international agency interaction & submission support
- • Design controls & quality system integration
- • Risk management (ISO 14971)
- • Guidance on phase-appropraite QMS
- • 21 CFR, ISO, MDR/IVDR, and MDSAP expertise
Clinical Research & Operations
Sigma designs clinical strategies that balance scientific rigor with operational feasibility and regulatory acceptance.
- • Clinical strategy & endpoint selection
- • Protocol and clinical document development
- • CRO selection & management
- • Investigator & site engagement
- • Operational strategy, including filling fractional roles (e.g., PM or PD)
- • Investigator meetings & Troubleshooting and rescues
Market Success
We support post-market activities that meet regulatory requirements while generating meaningful, defensible real-world data.
- • Post-market surveillance planning
- • Clinical education support
- • Sales & marketing enablement (compliant)
- • Field assurance & complaint handling
- • Ongoing regulatory compliance support
KOL Engagement
We are connected with over a hundred physician key opinion leaders, industry subject matter experts, and other scientific minds that can be tapped for:
- • End user/voice of customer
- • Product preference and publications
- • Investigators
- • Board members: company, scientific advisory, steering committee
- • Surgical wetlab and training
- • Comprehensive event planning
Due Diligence
- • Commercial/market strategy due diligence
- • Technical due diligence
- • Regulatory compliance and development strategy due diligence
- • M&A advisement
- • Can support Manufacturer, VC, PE, family offices, & investment banking
Let’s Build With Sigma
Whether you are early-stage or post-market, Sigma Bio Consulting helps align science, medicine, regulation, and business, and execution.