Molgenium
Consulting and CDMO-style services covering regulatory strategy and submissions, GMP/ICH implementation, nucleic-acid manufacturing from research to GMP grade, analytical development and QC, tech transfer and scale-up, pharmacovigilance, and training. The organisation provides software-enabled regulatory intelligence and AI-driven process automation to support audit readiness, method lifecycle management, and lifecycle regulatory submissions.
Industries
Nr. of Employees
small (1-50)
Molgenium
Düsseldorf, Nordrhein-Westfalen, Germany, Europe
Products
Regulatory intelligence and process automation platform
Modular platform supporting regulatory intelligence, CMC documentation and method lifecycle management, pharmacovigilance workflows and audit traceability across paper, hybrid or fully digital environments.
GMP-grade raw materials for RNA production
Catalog of GMP-grade enzymes, transcription buffers, capping enzymes and other raw materials to support IVT mRNA production and analytics.
Off-the-shelf and scalable mRNA production services
Catalog mRNAs and scalable GMP manufacturing services from milligram to gram scale with full QC and regulatory documentation for preclinical and clinical supply.
Regulatory Strategy
Global compliance expertise from IND to commercial approval, navigating complex pathways.
Chemistry, Manufacturing, and Controls (CMC) Fundamentals: Regulatory Strategy, Development, and Compliance
A specialized regulatory program designed to provide comprehensive understanding of Chemistry, Manufacturing, and Controls requirements for pharmaceutical and biotechnology products.
Interim Regulatory
Experienced interim professional to temporarily fill the Clinical Operations Director role.
Regulatory intelligence and process automation platform
Modular platform supporting regulatory intelligence, CMC documentation and method lifecycle management, pharmacovigilance workflows and audit traceability across paper, hybrid or fully digital environments.
GMP-grade raw materials for RNA production
Catalog of GMP-grade enzymes, transcription buffers, capping enzymes and other raw materials to support IVT mRNA production and analytics.
Off-the-shelf and scalable mRNA production services
Catalog mRNAs and scalable GMP manufacturing services from milligram to gram scale with full QC and regulatory documentation for preclinical and clinical supply.
Regulatory Strategy
Global compliance expertise from IND to commercial approval, navigating complex pathways.
Chemistry, Manufacturing, and Controls (CMC) Fundamentals: Regulatory Strategy, Development, and Compliance
A specialized regulatory program designed to provide comprehensive understanding of Chemistry, Manufacturing, and Controls requirements for pharmaceutical and biotechnology products.
Interim Regulatory
Experienced interim professional to temporarily fill the Clinical Operations Director role.
Services
GMP audits, mock inspections, remediation, QMS implementation and CAPA management to prepare organisations for regulatory inspections.
Custom mRNA, circRNA, siRNA, sgRNA, DNA oligos, gene synthesis, codon optimisation, plasmid preparation and peptide synthesis across research and GMP grades.
Analytical method development, method transfer, stability programs, environmental monitoring and reference standard qualification with regulatory‑grade Certificates of Analysis.
Regulatory strategy development, preparation of IND/IMPD/CTA and marketing applications, eCTD formatting and agency interaction support delivered on a project or retainer basis.
Defined-scope project delivery for submissions, remediation, QMS implementation and inspection readiness with fixed pricing, dedicated teams, set milestones and formal quality reviews.
Structured and on-demand courses covering regulatory affairs, pharmacovigilance, CMC, GMP and data integrity delivered in-person, virtual instructor-led or e-learning formats.
GMP audits, mock inspections, remediation, QMS implementation and CAPA management to prepare organisations for regulatory inspections.
Custom mRNA, circRNA, siRNA, sgRNA, DNA oligos, gene synthesis, codon optimisation, plasmid preparation and peptide synthesis across research and GMP grades.
Analytical method development, method transfer, stability programs, environmental monitoring and reference standard qualification with regulatory‑grade Certificates of Analysis.
Regulatory strategy development, preparation of IND/IMPD/CTA and marketing applications, eCTD formatting and agency interaction support delivered on a project or retainer basis.
Defined-scope project delivery for submissions, remediation, QMS implementation and inspection readiness with fixed pricing, dedicated teams, set milestones and formal quality reviews.
Structured and on-demand courses covering regulatory affairs, pharmacovigilance, CMC, GMP and data integrity delivered in-person, virtual instructor-led or e-learning formats.
Expertise Areas
- Regulatory compliance and submissions (FDA/EMA/ICH)
- GMP consulting, audit readiness and remediation
- Nucleic acid and oligonucleotide manufacturing (research to GMP)
- Analytical development, method validation and QC
Key Technologies
- In vitro transcription (IVT)
- Solid‑phase oligonucleotide synthesis
- High‑performance liquid chromatography (HPLC)
- Liquid chromatography–mass spectrometry (LC–MS)
News & Updates
Overview of regulatory affairs responsibilities, key regulatory bodies, submission templates, audit readiness and resources to track regulatory changes.
Guidance on supplier qualification, risk assessment, supplier audits and demonstrating supplier oversight during inspections.
Discussion of GMP audit checklists, tech transfer frameworks, lean manufacturing tools, contamination control and digitalising quality systems (Pharma 4.0).
Stepwise overview for EU GMP certification including pre-assessment, QMS implementation, internal audits, regulator engagement and post-certification continuous improvement.
Review of QC and CMC topics including method validation (HPLC, dissolution), stability studies, troubleshooting OOS/OOT, ALCOA+ data integrity and platform approaches for mRNA QC.
Overview of consultancy services in GMP, regulatory affairs and clinical study support and considerations for mRNA therapeutics quality control.
Overview of regulatory affairs responsibilities, key regulatory bodies, submission templates, audit readiness and resources to track regulatory changes.
Guidance on supplier qualification, risk assessment, supplier audits and demonstrating supplier oversight during inspections.
Discussion of GMP audit checklists, tech transfer frameworks, lean manufacturing tools, contamination control and digitalising quality systems (Pharma 4.0).
Stepwise overview for EU GMP certification including pre-assessment, QMS implementation, internal audits, regulator engagement and post-certification continuous improvement.
Review of QC and CMC topics including method validation (HPLC, dissolution), stability studies, troubleshooting OOS/OOT, ALCOA+ data integrity and platform approaches for mRNA QC.
Overview of consultancy services in GMP, regulatory affairs and clinical study support and considerations for mRNA therapeutics quality control.