Advanced pharmaceutical solutions

Where pharma science meets next-level precision

Expert solutions in GMP, CMC, Regulatory Affairs, Pharmacovigilance, and Preclinical & Clinical Studies, enhanced by AI and automation to accelerate drug development.

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6Drug modalities, from small molecules to ADCs
6-stepManufacturing validation lifecycle
End-to-endFrom discovery to GMP manufacturing
GlobalAligned with FDA, EMA and ICH guidelines

Aligned with global regulatory standards

  • GMP
  • ICH Q7–Q10
  • FDA
  • EMA
  • EU MDR
  • ISO 13485
  • ISO 14971
  • MDSAP
What we do

Services and products across the drug development lifecycle

All services
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Pharma & Biotech

Pharma & Biotech Services

CMC development, GMP services, regulatory intelligence and pharmacovigilance, from molecule to market.

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Medical Devices

Medical Device Services

ISO 13485-compliant development, quality assurance, audits and certification, and pharmacovigilance.

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Synthetic biology

Gene Design & Synthesis

Genes, oligos, mRNA, CRISPR tools, proteins and peptides, designed and quality-assured by Molgenium with our partner GenCefe.

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Consulting

Consulting Engagements

Advisory, project-based, retainer, interim management and dedicated-team models to fit how you work.

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Products

RNA Synthesis Raw Materials

High-purity raw materials for RNA synthesis, designed to accelerate your research and development.

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Digital

VAIO-PV

The validated AI operating system for pharmacovigilance and quality management, built GxP-first.

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How we help

Expertise at every stage, from development to post-market

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Drug modalities

Mastery across all drug modalities

From discovery to development, we bring deep expertise in every modern therapeutic approach to accelerate your drug development journey.

Small Molecules

Orally bioavailable compounds targeting intracellular pathways with high specificity and tunable pharmacokinetics.

Biologics

Large, complex proteins like monoclonal antibodies designed for high-affinity targeting of disease mechanisms.

Peptide Therapeutics

Mid-sized molecules bridging the gap between small molecules and biologics, offering high specificity.

Cell & Gene Therapy

Treatments that modify or replace genetic material to treat disease at its root cause.

Oligonucleotides

Short nucleic acid chains that modulate gene expression with precision, reaching 'undruggable' pathways.

Antibody-Drug Conjugates

Monoclonal antibodies combined with potent payloads to deliver therapy directly to diseased cells.

Why Molgenium

Deep scientific expertise, built for compliance

We combine deep scientific expertise with modern technology to deliver lasting value and accelerate your journey to market.

Regulatory insight

Proactive guidance to navigate complex global compliance landscapes with confidence.

AI-powered efficiency

Machine learning that optimizes processes and shortens development timelines, with full traceability and data integrity.

End-to-end platform

An integrated service from discovery to GMP manufacturing.

Modular and compliant

Each module aligns with ICH, EMA, FDA and ISO standards for global compliance.

Built-in risk management

Risk assessment (ICH Q9) integrated into every stage for continuous improvement.

Adapts to your workflow

Paper-based, hybrid or fully digital: we support the documentation model you run today.

Strategic implementation

GMP & ICH implementation, right the first time

We embed GMP and ICH compliance into your process DNA as a strategic foundation, not an afterthought, so your systems are audit-ready, scalable and scientifically sound from day one.

Gap analysis & roadmap

We assess your state against ICH Q7–Q10 and EU/FDA GMP, building a prioritized, risk-based roadmap aligned with your goals.

Design quality into systems

We co-design documentation and workflows using QbD principles, so compliance is built in.

Train & embed culture

Role-based GMP/ICH training with real-world scenarios ensures your team owns compliance as a core value.

Document & digitize

Lean, audit-proof documentation systems (SOPs, logs) with version control to reduce errors.

Audit simulation & CAPA

Mock audits stress-test your system, and robust CAPA workflows turn findings into improvements.

Sustain & scale

Metrics and reviews keep your GMP system evolving and inspection-ready.

Manufacturing validation

Our manufacturing validation process

Our validation doesn't just check boxes. It builds commercial confidence and de-risks your entire development pathway.

Three scientists reviewing results on a tablet Step 01

Protocol Design & Risk Mapping

We co-develop science-driven validation protocols with risk-based approaches (ICH Q9) to focus on critical process parameters that impact quality.

Overview of a manufacturing hall with process equipment Step 02

Installation & Operational Qualification (IQ/OQ)

We verify equipment and systems are installed correctly and operate within defined ranges, ensuring reproducibility from day one.

Bottles moving along an automated filling line Step 03

Performance Qualification (PQ)

We execute real-world runs under commercial conditions to prove consistency, yield, purity and compliance, batch after batch.

Scientist recording results at an analytical instrument Step 04

Documentation & Regulatory Package

We deliver audit-ready documentation: protocols, reports, deviations and traceability, aligned with FDA/EMA/ICH guidelines.

Gloved hand operating a laboratory instrument Step 05

Continuous Process Verification (CPV)

We implement real-time monitoring and statistical control to keep your process in a state of control, even post-approval.

Technicians in protective suits working in a cleanroom Step 06

Commercial Readiness & Tech Transfer

We prepare your validated process for seamless tech transfer to internal or external manufacturing sites, accelerating time-to-market.

The Molgenium validation impact

De-risk the pathway, unlock the value

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Faster timelines

Average reduction by avoiding rework with our first-time-right validation strategies.

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Passed inspections

Our documentation has a proven track record in regulatory inspections.

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Cost reduction

Focus resources on what matters and reduce the cost of poor quality.

Molgenium + Novoprotein

A synergistic partnership for mRNA therapeutics

A one-stop CDMO service platform from non-clinical research to IND application, combining Molgenium's RNA synthesis platform with Novoprotein's enzyme technology.

  • End-to-end mRNA process development
  • Analytical method development & validation
  • Research-grade mRNA production at scale
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Research

Joint discovery and innovation

Development

Therapeutic candidate optimization

Production

GMP manufacturing at scale

Delivery

Commercial product distribution

Knowledge base

Insights and resources for pharma professionals

Science meetings
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Blog

Articles on regulation, quality and development

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Free toolkit

Checklists for regulatory pitfalls, QC labs and data integrity

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Professional courses

Expert-led pharmaceutical training programs

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Talk to our experts

Ready to move your program from molecule to market?

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Contact

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Business hours

Monday – Friday, 9:00 AM – 5:00 PM CET

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