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 & target 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 & rescues
Market Success
We help you plan for market success from the beginning...and then support post-market adoption and compliance
- Market research, reimbursement, and HEOR
- Competitive positioning
- VAC Pack Creation
- Launch planning and execution
- Sales training & clinical education support
- Post-market surveillance
- Field assurance and on-going regulatory compliance
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
- • 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.