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