Solution
CMC–PHARMAPILOT
Strategy | Science | Service
Let’s Take Off to Your Destination
To give you an idea of where we can take you, we have clustered our expertise into four main areas: Strategic and Scientific Consulting, Technical Writing, Project Management, and IT/Digitalization/AI. All clusters are related to one or more of the three sectors covered by CMC-Pharmapilot: strategy, science and service.
With our experience, we build a bridge between GMP/Quality Assurance and Regulatory Affairs CMC to ensure smart regulatory strategies, compliant dossiers and smooth registration processes, supported by high quality data, lean processes and sound science.
With our experience, we build a bridge between GMP/Quality Assurance and Regulatory Affairs CMC to ensure smart regulatory strategies, compliant dossiers and smooth registration processes, supported by high quality data, lean processes and sound science.
We support all phases of a drug product, from start of phase I to the end of the product lifecycle.
Clinical Development
Phase I-III
Marketing Authorization
Approval & Product Launch
Growth Phase
Increasing Health Authority approvals & product quantities
Established product
Changes & Transfers
End of product lifecycle
Divestment / Pruning
Strategic and Scientific Consulting
Supporting you in creating new opportunities for growth and innovation
Development of CMC and Regulatory Strategy
- Balance GMP Restriction and CMC Options
- Optimization of Dossier Design to minimize consecutive Changes
- Transformation of multiple GMP data into meaningful and selected CMC data presentation
Scientific expert guidance for
- Process Criticality, validation, and Quality Control Strategy
- Definition of GMP window / Justification of Starting Material
- Briefing Books
Dossier compliance checks
- Verification of compliance with current regulatory guidelines
- Check of regulatory compliance of the current manufacturing practice against the registered dossier
- Due Diligences
Optimize Business Processes & Quality Management System
- Process standardization, leveraging data and match IT systems/applications
- Lean and compliant SOP architecture
- Support in preparing Health Authority inspections and remediation activities
Technical Writing
Compliant and consistent documents as enabler for success
Technical Writing for
- CTAs/INDs, NDAs/BLAs, Variations, and Renewals
- IMPDs, Module 2.3 and 3 (Quality Overall Summary / Technical Registration Reports), ASMFs/DMFs and CEP applications
- Responses to Deficiency letters
Compendial Monographs / Quality Control
- Development and preparation of Compendial Analytical Method
- Strict Quality Definition (exclusivity) according to Technical Guide
- Interpretation and impact assessment of Monographs and General Chapter
Standard Operating Procedures (SOPs)
- Revision of existing SOPs and creation of new SOPs
- Restructuring and trimming your SOP landscape
Quality Assurance Agreements (QAAs)
- Verification of paragraphs
- Creation of case specific operational aspects and attachments
- Supplier qualification, risk mitigation, and maintenance
Project Management
Successfully steer your projects in time and budget
Project management for major submissions: From change control over dossier preparation to deficiency letter handling
Transfer Manager
- GMP Transfer Organization and Milestone Scheduling
- Strategic Regulatory Change Planning
NCE Launch Coordinator
- Support Launch Production Phase to Commercialization
- Coordination of internal and external Material Flow and Registration