Pharmaceutical Development
Expert formulation and process development for sterile injectable drug products
Excipient compatibility and selection
Packaging development
Product contact surface compatibility studies
Filtration studies
Mixing and shear studies
Temperature studies
Container closure integrity studies
Scalability studies
Technology Transfer
We take a Quality by Design (QbD) approach in accordance with ICH Q8 to ensure critical processing parameters (CPPs) are verified against critical quality attributes (CQAs)
Analytical Services
Comprehensive analytical services
Our expert team provides full analytical, microbiology and stability services to ensure that your raw materials, bulk product and finished products are qualified, analyzed and released to cGMP standards.
Our services include:
Analytical
- Raw material and drug product method development and validation
- Cleaning method development & validation
- Extractable & Leachables
Microbiology
- Method development and validation for bacterial endotoxin, sterility, preservative effectiveness, bioburden and foreign particulate matter
Stability
- Full in-house stability storage and testing services to support clinical, registration and commercial stability programs
- ICH stability storage and testing
Regulatory support
Accelerating regulatory submissions and approvals
We support our customers in all regulatory phases from early phase clinical studies through to commercial product life cycle management providing:
- Full regulatory support for product registrations and post-approval changes
- “Ready to file” CMC documentation package in eCTD format
- Lifecycle management support
- Experience in registrations in all major markets
Pharmaceutical Development – Expert formulation and process development for sterile injectable drug products
We take a Quality by Design (QbD) approach in accordance with ICH Q8 to ensure critical processing parameters (CPPs) are verified against critical quality attributes (CQAs)
Excipient compatibility and selection
Packaging development
Product contact surface compatibility studies
Filtration studies
Mixing and shear studies
Temperature studies
Container closure integrity studies
Scalability studies
Technology Transfer
Analytical Services – Comprehensive analytical services
Our expert team provides full analytical, microbiology and stability services to ensure that your raw materials, bulk product and finished products are qualified, analyzed and released to cGMP standards.
Our services include:
Analytical
- Raw material and drug product method development and validation
- Cleaning method development & validation
- Extractable & Leachables
Microbiology
- Method development and validation for bacterial endotoxin, sterility, preservative effectiveness, bioburden and foreign particulate matter
Stability
- Full in-house stability storage and testing services to support clinical, registration and commercial stability programs
- ICH stability storage and testing
Regulatory support – Accelerating regulatory submissions and approvals
We support our customers in all regulatory phases from early phase clinical studies through to commercial product life cycle management providing:
- Full regulatory support for product registrations and post-approval changes
- “Ready to file” CMC documentation package in eCTD format
- Lifecycle management support
- Experience in registrations in all major markets