Sterile Injectable & Parenteral
Drug Product Development
Our Injectable Formulation Services support the development of sterile parenteral drug products through scientifically
driven formulation design, process understanding, and quality-focused execution.
We work across a wide range of injectable dosage forms to address solubility, stability, sterility,
and delivery challenges associated with parenteral products.
Injectable Development Overview
Injectable dosage forms require precise control over formulation composition, sterility assurance, and physicochemical stability.
Our injectable development approach integrates pre-formulation insights, formulation science, analytical support, and stability considerations to enable robust and reproducible parenteral product development.
We support both simple and complex injectable systems, addressing molecule-specific challenges and intended routes of administration.
Injectable Dosage Expertise
By integrating drug delivery science with manufacturing insight, we support the translation of lab-scale injectable formulations into robust development-stage products with consistent performance across batches.
Key Capabilities
Nanosuspensions & Emulsions:
Development approaches for poorly soluble molecules requiring parenteral delivery.
Solutions:
Ready-to-use or lyophilized formulations for IV, IM, or SC administration.
Suspensions:
Formulation strategies for sustained or depot injectable delivery.
Microparticles & Lipid-Based Systems:
Controlled and targeted release approaches for specialty parenteral products.
Selection of appropriate injectable systems during development supports formulation stability, manufacturability, and lifecycle planning.
Differentiated Generic & Specialty Parenteral Development
We support the development of differentiated generic and specialty parenteral products through structured formulation and process development activities designed to address complex injectable challenges.
Our injectable development capabilities are applicable across clinical-stage programs and commercial development pathways, with focus on formulation robustness, manufacturability, and lifecycle considerations.
- Advanced formulation strategies for complex injectables
- Process understanding to support scale-up readiness
- Container–closure and packaging compatibility evaluation
- Integration of analytical and stability data
These activities support clinical development continuity and commercial readiness planning.
Quality, Compliance & Development Alignment
Injectable formulation development activities are conducted within structured quality systems, ensuring data integrity, traceability, and alignment with applicable regulatory expectations.
- Documented formulation and development activities
- Integration with analytical and stability programs
- Support for development-stage regulatory documentation
- Alignment with manufacturing and technology transfer needs
Why Injectable Formulation Matters
Injectable products place high demands on formulation design due to sterility requirements, delivery route considerations, and stability constraints.
- Supports reliable sterile product quality
- Reduces formulation and scale-up risk
- Enables consistent manufacturing performance
- Strengthens technical and regulatory documentation
Looking for a Trusted Pharmaceutical Partner?
Let’s discuss how our pharmaceutical capabilities can support your requirements.