Consulting chemical engineer · Melbourne · AU / NZ / Vietnam
Get to GMP. Scale it up. Fund it.
Herbal Medica helps regulated manufacturers pass audit, scale a process from bench to plant, and recover the cost through R&D Tax Incentive and grants. All of it comes from one senior engineer who has taken a medicinal cannabis facility from construction to GMP-compliant production.
- 30+ years in chemical engineering, QA and regulated manufacturing
- TGA · ODC · NATA audit and licensing experience
- Conference speaker ACannabis 2026, Melbourne
The bar is rising. Budgets aren't.
Australia's medicinal cannabis and botanical manufacturers face tighter TGA enforcement, likely reform of unapproved-product pathways, and falling revenue at the same time. Most can't justify a full-time senior QA or process engineer. One compliance failure can still cost the licence.
Herbal Medica gives you that senior expertise when you need it, scoped to the problem, priced up front, and focused on protecting the licence, the batch and the cash.
Services
Four disciplines, one adviser
Most firms cover one or two of these areas. Herbal Medica covers all four, so nothing gets lost in the handover between the engineer, the quality manager and the grant writer.
GMP, GACP & Quality Systems
Build and run the quality system that passes audit and keeps you in production.
- QMS design, SOPs, batch manufacturing and packaging records
- GACP/GMP gap assessments and internal audits
- QC-to-QA transition for scaling manufacturers
- Deviation, CAPA and complaint investigation
- Interim QA or production leadership
Regulatory & Compliance
Practitioner-level experience with TGA, ODC and NATA, not generic compliance advice.
- TGA, ODC, NATA and HACCP compliance strategy
- Audit preparation and representation
- Import/export permits for flower and finished product
- PIC/S alignment and ARTG-readiness assessment
- GHS classification and labelling reviews
R&D Chemical Engineering & Scale-up
Take a process from bench to pilot to commercial scale, with the financials to back the decision.
- Process development and scale-up basis of design
- Technology transfer and operational readiness
- CAPEX, OPEX and cost-of-goods modelling
- Techno-economic assessment and make-versus-buy
- Commissioning, IQ/OQ/PQ and validation
Funding: R&D Tax & Grants
Non-dilutive capital for operators who need cash without giving up equity.
- Grant program identification and proposal writing
- R&D Tax Incentive scoping and technical narratives
- Audit-ready research record-keeping
- Preparation for the R&DTI changes from 1 July 2028
Analytical Chemistry & Method Development
HPLC, GC and UV-Vis method development and validation. Thin-layer chromatography reference portfolios to detect species substitution and adulteration in herbal raw materials. Stability trial design, active-ingredient profiling, and reviews of LIMS data integrity.
How we work
Fixed scope. Fixed price. Clear go/no-go.
Every engagement starts with a free 20-minute call. You then get a written scope and a fixed price before any work begins.
Compliance packages
GMP / GACP Gap Assessment
A site and document review against TGA, ODC and PIC/S expectations. You get a costed, prioritised remediation plan.
Audit-Readiness Sprint
Focused preparation before a TGA, ODC or NATA inspection: mock audit, document fixes and team briefing.
ARTG Readiness Diagnostic
Where your products stand if unapproved-product pathways tighten, and what it would take to register.
Scale-up stage-gates
- Gate 1
Feasibility & concept economics
Bench data review, route options, order-of-magnitude CAPEX/OPEX and an indicative cost of goods. Cheap insurance against a bad capital decision.
- Gate 2
Basis of design & techno-economic model
Mass and energy balance, equipment specification and a full cost model with sensitivities, plus the regulatory pathway.
- Gate 3
Implementation & operational readiness
Procurement support, technology transfer, commissioning and qualification, SOPs, training and validation.
Ongoing support
Regulatory Watch
A quarterly regulatory briefing plus a set number of advisory hours each month.
QA on Call
A named senior quality adviser with a monthly system review.
Interim Leadership
Embedded QA or production leadership for a greenfield build, audit cycle or product launch.
Technology partner
Authorised agent for LiLiChro in Australia, New Zealand & Vietnam
Herbal Medica is the authorised agent in Australia, New Zealand & Vietnam for LiLiChro, a European manufacturer of preparative liquid–liquid (centrifugal partition) chromatography systems. A separation method developed on the smallest unit scales linearly to industrial production.
| System | Scale | Typical use |
|---|---|---|
| miniLiLi | Laboratory | Method development and feasibility |
| midiLiLi | Gram scale | Preparative work and reference standards |
| maxiLiLi | Kilogram scale | Pilot and mid-volume production |
| prepLiLi | Industrial | High-volume purification |
What makes it different: Herbal Medica can supply the instrument, then qualify it (IQ/OQ/PQ), transfer the validated method and write the GMP documentation. You don't need to coordinate a separate contractor for each step.
Independence statement. Herbal Medica discloses this agency interest in every advisory engagement. Every technology comparison we prepare includes alternatives from other suppliers.
Track record
Hands-on delivery across regulated industries
Medicinal cannabis & pharmaceutical
- Greenfield facility: from construction through to GMP-compliant medicinal cannabis production
- Production Manager, Nectarbrands Portfolio: bulk import, GMP packaging, ODC/TGA liaison, Power BI reporting
- QA Manager, Medcan Australia: GACP/GMP systems, finished-product import and pharmacy supply
- Senior GMP Process Specialist, ANTG ABC Can: post-harvest compliance and bulk API export
- QC & Validation Chemist, Integria Healthcare / MediHerb: TLC reference portfolio and HPLC/GC methods for herbal raw materials
Chemicals, agriculture & environment
- Laboratory Team Leader / HSEQ, Queensland Nitrate Plant: GHS, environmental reporting, data integrity
- Designed, built and commissioned a high-risk-compliant sample point in the reformer stage of ammonia production
- Led a triennial shutdown of a Major Hazardous Facility, including gas monitoring, confined-space oversight and drug and alcohol testing
- QA Laboratory Manager, Ridley AgriProducts: HACCP, GlobalG.A.P., BAP and PFIAA certification
- Hydrogen-to-fuel-cell research and wastewater treatment for underground coal gasification
- Hungarian Academy of Sciences: analytical support to the national environmental review for Hungary's EU accession
About
Krisztina Lozsi Emmerson
Founder · Consulting Chemical Engineer & Regulatory Compliance Specialist
Krisztina holds an M.E. in Chemical Engineering from the Budapest University of Technology and Economics and the University of Veszprém, as well as a Graduate Diploma in Management. She is completing her MBA at the Australian Institute of Business, due by the end of 2026. She has also completed a Certificate IV in Project Management and is working towards becoming a Certified Digital Marketing Associate in AI for Business and Marketing.
Her career covers medicinal cannabis manufacturing, pharmaceutical GMP, agriculture, environmental science and major hazardous facilities in Europe and Australia.
She also works as a peer reviewer and scientific advisor for publications in analytical chemistry and related fields. She is closely involved in evidence-based drug policy: she is a board member of Students for Sensible Drug Policy Australia, a member of the Medicinal Cannabis Council Australia and Pill Testing Australia, and a drug-checking scientist with Victorian Pill Testing Services.
Insights
Notes from the lab and the regulator's desk
Harm reductionDrug checking: how it works around the world
Drug checking is on-site or lab-based testing that identifies and quantifies substances in drugs supplied by users or collected at events. Methods range from reagent tests and portable FTIR and Raman spectrometers to GC-MS and LC-MS.
Models. Festival and nightlife services are widely used in Europe, parts of Australia and New Zealand. Fixed-site community services are common in Europe and growing in North America. There are also mobile outreach units, and national surveillance programs such as wastewater analysis.
Benefits. Drug checking detects dangerous adulterants such as fentanyl and novel psychoactive substances, and supports public-health early warning. People often change what they do when results are unexpected. The data also supports evidence-based policy.
Limits. Field methods can miss low-concentration adulterants, legal barriers remain in some jurisdictions, and high-quality equipment and trained staff are expensive. Rapid on-site tests also trade some accuracy for speed.
Contact
Let's find the right solution together
Start with a free 20-minute call. You'll leave with a clear view of the risk and the next step, with no obligation.
- Phone
- +61 400 403 556
- Based in
- Melbourne, Victoria. Serving Australia, New Zealand and Vietnam