Option One supports pharmaceutical, biotech and medical device companies with senior-led regulatory, GMP compliance, inspection readiness and operational excellence programs across Europe, the United States and other regulated markets.
FDA | EMA | AIFA | Swissmedic | EU GMP | US cGMP
30+ years of senior industry experience
Projects delivered across international regulated markets
FDA, EMA, AIFA and Swissmedic experience
Senior experts available for on-site, remote and hybrid assignments
Senior Life Science Expertise
Global Regulatory Execution
Where people make the difference.
ABOUT US
Option One Life Science Consulting is a Swiss-based boutique consulting firm supporting pharmaceutical, biotech and medical device organizations with regulatory, quality, compliance and operational expertise.
We combine senior leadership, hands-on execution and a scalable network of carefully selected professionals to address complex projects across international regulated markets.
Our model:
Each engagement is coordinated through a single accountable project structure. Based on the client’s needs, Option One assembles the appropriate combination of QA, Regulatory Affairs, Sterility Assurance, Microbiology, Validation, Engineering, Technology Transfer and Medical Device expertise.
This model provides clients with direct access to senior professionals while preserving flexibility, continuity and clear accountability.
INDUSTRY EXPERTISE
Built for complexity. Trusted for outcomes.
We specialize in highly regulated, technically demanding environments. Whether you're scaling, remediating, or launching — we bring clarity, execution, and results.
Sterile Manufacturing
Hands-on support in aseptic processing, media fill execution, cleanroom zoning, and contamination control.
High Potent Compounds (HPC)
Expertise in HPC facility setup, including:
Containment strategy definition
Isolator-based design integration
SME training and risk mitigation.
API Manufacturing
Field experience in API production, quality control, and regulatory strength.
Quality Control Laboratories
We turn labs into high-performance assets:
Method transfers and validation
Data Integrity frameworks
Operational excellence initiatives
Medical Device
Expertise in Medical Device development and manufacturing:
Risk-based product design
Regulatory pathway definition (EU MDR, FDA, etc.)
QMS integration from concept to market launch
SOLUTIONS
We provide both advisory and hands consulting support for the Life Science industry across Europe and other regulated markets around the world.
Focus areas include Pharmaceutical (API, Finished Products), Medical Devices and Biologics.
REGULATORY AFFAIRS
We offer comprehensive support in regulatory affairs to ensure full compliance with international standards for pharmaceuticals, medical devices, and biotech products.
What we do:
Preparation and review of regulatory dossiers
Authority liaison and submission management
Support during product registration and lifecycle maintenance
COMPLIANCE
We guide companies through remediation and FDA/EMA/Swissmedic inspection readiness programs with a focus on practical gap closure and sustainability.
How we help:
gap analysis;
mock inspections;
readiness assessment
document review;
SME coaching;
inspection-room simulations;
CAPA and remediation governance;
support during inspection and response preparation.
TECHNOLOGY TRANSFER & OPERATIONAL EXCELLENCE
We support tech transfer projects and help optimize manufacturing operations by aligning technical execution with regulatory expectations and business objectives.
Areas of focus:
Site-to-site process transfer
Process optimization and risk reduction
Deployment of lean and data-driven practices
RESPONSIBLE PERSON (RP) - Switzerland
We provide GDP/GMP-compliant Responsible Person (RP) services based in Canton Ticino, fully aligned with Swissmedic requirements — ideal for companies looking to operate in the Swiss market.
Why it matters:
Local presence with regulatory fluency
Supervision of distribution and supply chain activities
Support during audits and health authority inspections