ISALYS Life Sciences Inc.
Expert-led consulting and operational support.
From development to FDA readiness.
A dedicated US operations team, backed by a decade of European operational depth. Serving pharmaceutical, biopharma and CDMO/CMO operations across the Boston–Philadelphia corridor.
10 yrs
Supporting pharma & CDMO leaders
500+
50+
85%
98%
Trusted by
Why isalys
"Have you done this in the US?" Fair question.
Here's what ten years in Europe and a dedicated New York team bring to the table.
FDA-facing expertise
Our expert network brings FDA-facing experience: submissions, inspection readiness, US regulatory expectations. A PAI passed is part of our track record.
The transatlantic bridge
Our European clients operate US sites. Transatlantic technology transfer is our natural ground, where mastering both EMA and FDA frameworks is a real advantage.
Local, not remote
Operations leadership based in New York. Not a representative office: a delivery organization.
Who we are
A founder-led European group, now operating in New York
ISALYS Life Sciences is a long-established specialized (bio)pharmaceutical consulting firm in France and Belgium, part of ISALYS Group, an independent consulting and engineering group founded in 2016 and still led by its founders.
In 2026, we established ISALYS Life Sciences Inc. in New York, with a local operations leadership, built to serve the corridor's pharmaceutical, biopharma and CDMO/CMO sites.
Independent and founder-led
No fund ownership. Decisions made by operators, for the long term.
Specialists, not generalists
Teams of pharmacists and specialized engineers: chemistry, biology, quality, regulatory, processes, analytical, qualification.
Local operations leadership
An operations director based in New York City, accountable for every US engagement.
our expertise
Five domains covering the drug lifecycle
You have never heard of us. Here is why pharmaceutical and CDMO leaders should still take the meeting.
Development
Pharmaceutical development (analytical, galenic), API synthesis, and medical device development. Precise support at every key stage of our clients' projects.
Industrialization & Manufacturing
Technology transfer, process optimization, maintenance and quality control, for reliable and efficient manufacturing operations.
Operational Performance
Qualification, capital projects and supply chain optimization, delivered within industrial standards and regulatory constraints.
Quality Assurance
Strengthening quality systems, supplier audits, operations analysis. Batch release secured at the highest quality level.
Regulatory Affairs
Regulatory dossiers and updates, inspection readiness and non-conformity management, across FDA and EMA frameworks.
how we deliver
A flexible 3-phase delivery model
Senior expert-led from audit to stabilization, with operational deployment on site when needed. Projects can mobilize one, two or all three phases, depending on your needs, maturity and level of urgency.
01
Audit & framing
The senior expert clarifies scope, priorities and methodology, and defines the target roadmap.
02
In-house preparation by ISALYS
The senior expert structures the intervention, aligns stakeholders and secures readiness conditions.
03
On-site execution & stabilization
Operational support is deployed on site, with expert oversight on key milestones, critical issues and the transition to routine operations.
our approach
ISA'touch: what makes working with us different
The method behind every ISALYS engagement, applied identically in Europe and in the US. Seven pillars, systematically deployed.
01
High-value talent
Professionals who share our values, with the technical skills and interpersonal qualities to accelerate client performance.
02
A senior expert network
Senior experts mobilized on the most demanding engagements: audits, assessments, training, recommendations.
03
ISA'tech: continuous innovation
Our internal knowledge hub: methods, tools, active watch, lessons learned and new capability development.
04
Tailored solutions
Every project is unique. Our responses are built at the intersection of technical expertise, domain experience and the right interpersonal fit.
05
One dedicated point of contact
A Business Manager accountable from scoping to delivery: understanding your challenges, mobilizing the right teams, ensuring value is delivered.
06
Flexible engagement models
From advisory to full on-site deployment: we adapt our level of involvement to your context and timeline.
07
Committed and agile teams
We commit to transparency, team stability, continuity of service, and proactive remediation when issues arise.
A structured follow-up framework on every engagement:
weekly check-ins, monthly tripartite reviews with your team, and a formal closure with lessons learned. You always know where the engagement stands.
Proven results
Results our clients can measure.
Engagements delivered for European pharmaceutical and CDMO leaders.
More references across the drug lifecyle
A selection of engagements, from development to compliance.
DEVELOP
Built a risk-based QbD program from scratch, turning a new chemical project fully validation and audit-ready.
European API manufacturer
Validated new analytical methods and drove their transfer to production, strengthening an entire product launch pipeline.
European API manufacturer
INDUSTRIALIZE
Launched the market's first all-in-one dental product, built on a line running 10x faster than manual.
Mid-size pharma
Delivered commissioning and qualification for a brand-new production building and filling line, right on schedule.
European CDMO
MANUFACTURE
Took the reins of a 70-person QC lab under MHRA/FDA scrutiny, zero disruption, zero compromise.
European CDMO
Scaled quality operations for a COVID-19 vaccine surge: production ramped from 700K to 1.6M vials.
Global CDMO
COMPLY
Led Annex 1 compliance engineering across 10 production lines, directing 10 project leads site-wide.
European CDMO
Rebuilt design control documentation for a Class III implantable device manufacturer, aligning with EU MDR.
European medical device manufacturer
Team and people
Engaged, curious, responsible people
ISALYS Life Sciences Inc. is led from New York by a local operations leadership, backed by the group's founders and its European expert network.
A network of senior experts, already at work
Behind every US engagement stands the group's established expert network: senior specialists with technical depth and FDA / EMA perspective, mobilized on the most critical project phases: audits, assessments, training and expert oversight.
110
20+
4
seniority levels, the right people for the right stage
Join us
Join the founding team of ISALYS in the US
We build the US team the same way we built the group: with people we trust, on a shared professional journey. Our collaboration model is founded on trust, commitment, respect for individuals and a focus on results.
CQV, QA, MSAT, regulatory — engineers and pharmacists who want to build, not just execute.
Fair, transparent recruitment
Selection based on competence, experience and potential. Structured interviews, no discrimination, ever.
Real management proximity
Structured onboarding, then weekly and monthly follow-up with a manager who knows your project. Not a name in a database.
Growth by design
Continuous training, transparent evaluation and career paths that reward skills development.
A safe and equitable workplace
A healthy, respectful and stimulating work environment, backed by the group's Ethics Charter and HR Policy.