Pharmaceutical

Botanical ingredients ready for your regulatory dossiers.

Every batch supplies with the full documentation expected by health authorities: cultivation data, 
CoA and GACP records.

Ready to integrate into Marketing Authorization dossiers without requalification.

What pharma demands from its biomass suppliers

A CDMO that integrates a botanical extract into a pharmaceutical formulation bears full documentation responsibility to health authorities. A Certificate of Analysis alone does not satisfy a Marketing Authorization dossier.


You need upstream data: certified variety, documented origin, batch-level cultivation records, harvest window, drying and processing parameters. Most botanical ingredient suppliers do not produce this data.

The result is requalification at every batch change. It means additional requests from authorities and longer regulatory timelines.
Horssol grows in a controlled, traceable environment from seed onward. Documentation is generated alongside production, not reconstructed after the fact.

Compliance

Standards we operate under

Our production process is structured around pharmaceutical and para-pharmaceutical standards.

Regulatory requirements are built into the cultivation protocol from day one, not retrofitted.

GMP

Post-harvest steps including drying, processing and packaging follow GMP requirements. Critical parameters are recorded at every stage.

GACP

The baseline standard for any plant-based biomass intended for pharmaceutical use. Certified variety, documented cultivation conditions, plot-level traceability, controlled harvest window.

CoA

Every delivered batch includes a full CoA: botanical identification, active marker assay, content screening

QA

Standardized procedures and quality assurance

Use cases

Why pharmaceutical manufacturers contact us

PHYTOTHERAPY CDMO - FRANCE

Disruption risk on an imported raw material

Your biomass supply depends on one or two non-EU suppliers.
A harvest variation, a logistics issue or a quality gap is enough to halt your production.

Horssol grows in Europe under controlled conditions, with year-round scheduled deliveries.

PHARMACEUTICAL LABORATORY - SWITZERLAND

Documented biomass for a new Marketing Authorization dossier

You are building the raw material section of a regulatory dossier and need biomass backed by full cultivation and analytical data.

Horssol provides structured documentation, ready for direct use by your CMC team or regulatory contractor.

BOTANICAL CONTRACT MANUFACTURER - BELGIUM

Batch-to-batch variability in active content

Active compound levels in your current biomass fluctuate with origin and season, which complicates extract standardization.

Controlled-environment production stabilizes the phytochemical profile batch after batch.

PHARMACEUTICAL GROUP - GERMANY

You need a specific phytochemical profile

You need a raw material with active marker content above what the market offers, or a profile tailored to a specific formulation.

Horssol can co-develop the cultivation protocol with your R&D team.