Option One Life Science Consulting is a boutique life science consulting firm specialising in turn key regulatory, compliance & operational excellence services across pharmaceutical, medical device and biotech industries.
Expertise You Can Trust.
Results You Can Measure.
People always make the difference.
ABOUT US
Where technical depth meets execution excellence
Founded by Alberto Magnani, a trusted GMP advisor with over 30 years of industry experience, Option One stands out for its hands-on approach, combining strategic insight with field-proven solutions.
Our promise:
To build long-lasting relationships based on trust and results
To deliver tailored, effective, and scalable consulting solutions
To help companies thrive in highly regulated environments
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:
System and documentation gap assessments
Corrective and preventive action (CAPA) development
Personnel coaching to face inspections with confidence
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