Our Services
Analytical Services
Contract GMP laboratory services supporting your respiratory drug development
Developments of respiratory products need a comprehensive and thorough approach. Our expertise from many projects involving DPIs, MDIs and nebulizers guides you to perform all required investigations supporting your development strategy to enter your first clinical trials and beyond. Our pharmaceutical scientists work with you at every stage of development, providing consistently high quality and flexible services.
Drug Products
- Pressurized Metered Dose Inhalers (pMDI)
- Dry Powder Inhalers (DPI)
- Nebulizer Solutions and Suspensions
- Nasal Sprays (aqueous, powder, and propellant driven)
Services
- In-vitro Bioequivalence Testing (test vs. reference product)
- Product Characterization Studies (e.g. Patient in-use / misuse, Cleaning Studies, etc.)
- All Activities to support IMPD/CTD module 3
- EU GMP Release
Our Services in Detail
- Analytical Method Development
- Analytical Method Transfer
- Analytical Method Validation
- ICH Stability Studies
- Development Support
- Reference Product Benchmarking
- Formulation Development Support
- Device Selection
- In Vitro Bioequivalence Studies to support Generic Submissions
- In Vitro Bioequivalence Studies to support Variations of Approved Products
- Clinical Batch Release
- Process Validation Support
- Temperature Cycling
- Effect Orientation During Dosing
- Definition of Cleaning Instructions
- Device Robustness Testing
- Priming and Repriming
- Effect of Varying Flow Rate
- Flow Rate Simulation
- Device Resistance
- Spacer Testing
- DIN EN 13544-1 Testing for Nebulizer Systems
- Transportation Studies
Consulting & Project Management
Best Practice Inhaler Projects
Our team has a proven track record of delivering inhalation solutions from concept to market launch and can provide you with all the support you need to achieve the optimum outcome for your project demand. Our team works with you to manage, coordinate or oversee your development Project
Project Management Support Services
- Definition of overall Product Development Strategy
- Project Management including Coordination of Partners
- Quality by Design and Design Control Set Up
- Regulatory Guidance
- Assessment of Development Partners
- Supplier and Partner Audits
- Support in Portfolio Management
Regulatory & IMPD
IMPD-Services – Your Pathway into the Clinic
We support you in cost-effective and timely solutions of your regulatory filings for clinical trials in Europe, the USA, and other regions of the world. We guide you in defining the regulatory roadmap for your inhalation product, and execute on time to achieve results in line with your objectives.
Our Services towards your Drug Approval
- Regulatory and Clinical Strategy
- Medical Device Submissions
- Audits at Suppliers and Development Partners
- IMPD Compilation
- Compilation of CTD Module 3
CTM Supply
Strong Partners for CTM Supply and Clinical Projects
Actarmo has a proven network of reliable partners for the clinical phase in your development project. We cooperate tightly with contract manufacturing partners:
- Device Assembly, Kit Configurations, Booklets, Package Inserts
- Drug Import, Reference Products
- Cooling Capacities 2 – 8 °C, Hazardous Substances
- Packaging and Labeling, Kit Assembly
- QP Release, GMP compliant Conduct and Documentation
- Storage and Distribution
Further, we cooperate with different Clinical Research Organizations that excel in respiratory disease indications.
- First-In-Man Studies
- Clinical Pharmacology
- In-vivo Bioequivalence, Pharmacokinetic Studies
- Clinical Flow-Profile Studies