What We Do

We deliver high-precision documentation and protocol development tailored to the veterinary pharmaceutical industry:

Standard Operating Procedures (SOPs)

• GMP/GLP-compliant SOPs for all laboratory activities, from experimental setup through to archiving

Validation Protocols

• Analytical method validation
• Process and cleaning validation

Technical Transfer & Dossier Preparation

• Technical transfer protocols for development and scale-up
• Dossier compilation for Active Substance Master File
• Stability protocols tailored to current international standards

Analytical Reports & Project Planning

• Detailed analytical reports including batch analyses, stability data, and      validation outcomes
• Development and maintenance of project plans for all development and scale-up activities

Our consultancy offers expert guidance across Chemistry, Manufacturing, and Controls (CMC), with solutions from concept to commercialiszation:

CMC & Formulation Advisory

• Technical support for all aspects of CMC (Quality)
• Advisory services for formulation design, troubleshooting, and reformulation strategies
• Capability to lead projects from preformulation through development pharmaceutics, trial batches, and full commercial production

Regulatory & Expert Documentation

• Gap analysis of dossiers and supporting data
• Expert Reports and Quality Overall Summaries (QOS) for regulatory submissions

Sourcing & Troubleshooting

• Sourcing of active substances via established global contacts
• Advanced troubleshooting of analytical challenges, with emphasis on chromatographic techniques and solid-phase extraction

Technical Transfer Leadership

• Assistance in technical transfer from guidance documents to full project ownership and execution