Senior scientific expertise, on demand — when your team needs it most.
Aesti gives pharmaceutical, biotech, CDMO and chemical organizations fast access to senior toxicology, occupational exposure, cleaning validation, impurity assessment, and product stewardship expertise — built on frameworks already proven across 80+ global manufacturing sites.
Expertise that works at the corporate level and the site level.
Most organizations need both. At the corporate level, the question is whether your occupational toxicology and hazard communication program is sound, current, and defensible across every site. At the site level, the question is what a specific substance, project, or shop floor needs this week. We plug in at the level the situation calls for.
For leadership setting the program every site works within.
For occupational health, product stewardship, EHS, and regulatory affairs leadership who need the program itself to be sound, current, and defensible — across every site, every time.
For teams who need an answer this week.
For heads of manufacturing, project managers, and site occupational health & quality specialists who need a fast, defensible answer for a specific substance, project, or audit.
Dr. Ester Lovsin Barle
PhD · MScTox · ERT — Principal Advisor, Aesti GmbHHer background combines senior corporate leadership with the standard-setting authority regulators and auditors measure against. That combination means engagements start with judgment already tested inside several global pharma companies — not applied from the outside looking in.
- Former global, corporate toxicology, occupational health and product stewardship leadership roles at Takeda, Lonza, Novartis, and Sandoz
- Toxicology and exposure-control frameworks deployed across 80+ global manufacturing sites
- Co-author, ASTM E3219-20 — the industry standard for HBEL derivation — and over 50 publications
Six connected areas of expertise.
Corporate & Program Level
For occupational health, product stewardship, EHS, and regulatory affairs leadershipProgram Audit & Remediation
We audit your occupational health and hazard communication program against regulatory expectations, flag the gaps that carry the most risk, support your remediation program.
Opinion Leadership & Position Papers
When your organization needs a defensible position — on an exposure limit, a classification decision, or an emerging hazard question — we build the rationale and author papers that hold up with regulators and customers.
Regulatory Audit & Defense
Occupational health, product stewardship, and product quality documentation built to withstand EHS audit and quality inspection — with direct support during site audits and regulator interactions.
Site & Substance Level
For heads of manufacturing, project managers, and site specialistsUnified Technical Monograph
One integrated document, built from a single defensible data set, satisfying HBEL/PDE, OEL/OEB, and CLP/GHS (SDS Sections 2 & 11) — instead of three separate deliverables from three separate work streams.
Fast-Track Substance & Hazard Tiering
For CDMOs taking on early-phase substances with incomplete data: send a SMILES string, and we return health hazard classification and occupational exposure band (OEB) within 48 hours.
Overflow & Surge Capacity
Rapid-turnaround support for internal project management, EHS, manufacturing science, and quality teams during peak workload, project spikes, or transitions.
Built to start fast — and fit exactly what the situation calls for.
Discovery First
Every engagement opens with a short scoping conversation to map the specific need, timeline, and stakeholders involved.
Flexible Engagement
Once scope is defined, work is structured as a fixed-fee project or an ongoing monthly retainer.
Fast Onboarding
Established frameworks and templates mean engagements can start quickly, with minimal ramp-up time.
Right-Sized Deliverables
From rapid technical memos to full reports, workshops, or on-site support — matched to what the situation calls for.
Corporate-side judgment. Standard-setting authority.
Corporate-side perspective
Having led toxicology, industrial hygiene, occupational health, and product stewardship functions inside a global biotech, Aesti understands the internal pressures and constraints your team is working within.
Standard-setting authority
Authorship of the framework used to assess compliance (ASTM E3219-20) brings a level of credibility few external resources can match.
Deliverables that land ready to use
Outputs are built to plug directly into your OEL banding, cleaning validation, or SDS process.
A trusted extension of the team
Engagements are designed to build internal capability and credibility, at both the program level and the site level.
Let's map the specific need, timeline, and stakeholders involved.
Every engagement starts with a short discovery conversation — no commitment required. Tell us what your team is facing, and we’ll help you find solution.