Formulation Development

Turn your drug concept into a clinically viable, scalable product with Eramol’s formulation development expertise. Our team supports early-phase trials through commercialisation, ensuring robust, compliant, and optimised formulations for your active pharmaceutical ingredients (APIs), including solid oral, capsule, and sterile liquid/vial products.

Clinical Formulation Development Expertise

Eramol works closely with clients to develop fit-for-purpose formulations across all dosage forms, tablets, capsules, liquids, sterile injectables, and nasal products, delivering optimal clinical outcomes and streamlined manufacturing. Our MRHA-approved, state-of-the-art facilities enable rapid, efficient formulation development for:

• First-in-Human studies
• Phase II–IV clinical trials
• Commercial-scale production

We also specialise in innovative placebo formulation development, ensuring blinded studies maintain integrity across the supply chain.

Expanded Capacity & Purpose-Built Facilities

Our Sevenoaks, UK site has been significantly expanded to include:

• Sterile liquid/vial manufacturing
• Enhanced solid oral dose development capacity
• Advanced placebo and comparator product development
• Expanded analytical testing and pilot-scale manufacturing

This investment ensures we can deliver high-quality, flexible formulation solutions for both clinical and commercial products, including sterile injectables.

Pre-Formulation Services

Eramol’s pre-formulation capabilities provide critical insight into API behaviour and formulation viability:

• Chemical compatibility and reactivity with packaging substrates
• Physical properties and product characterisation
• Accelerated degradation and photostability studies
• API-excipient interaction studies
• pKa determination and hygroscopicity testing
• Prototype evaluations
• De-formulation and reverse engineering

These studies provide a strong foundation for robust formulation development and successful clinical outcomes.

Formulation Development Services

Our development team offers a full range of clinical and commercial formulation services, including:

• Early Phase I rapid formulation and manufacturing optimisation
• Phase II–IV formulation development and reformulations
• Blending and analysis for tableting, encapsulation, sterile liquid/vial filling, and content uniformity
• Over-encapsulation and comparator product blinding
• Development of matching placebo formulations for blinded clinical trials

Placebo Formulation Development

Eramol ensures placebos match the physical and sensory properties of active products, including:

• Tablets and capsules: colour, shape, size, and taste
• Sterile liquids/vials: matching appearance, viscosity, pH, osmolality, and sensory characteristics
• Film coating or non-functional coatings to make placebos indistinguishable from active products

Our formulation scientists guarantee that blinding integrity is maintained across all clinical trials and dosage forms.

Analytical Method Development & Stability Studies

We provide comprehensive analytical services to support formulation development:

• ICH-compliant analytical method validation and verification
• Method transfer, co-validation, and full re-validation
• Full ICH stability testing, including accelerated, real-time, and transport stability studies

These services ensure robust, validated data to support regulatory submissions and product lifecycle management.

Pre-GMP Formulation & Pilot Manufacturing

Our pre-GMP formulation services prepare IMPs for pre-clinical and early-phase trials:

• Rapid formulation studies using platform technologies
• De-formulation to reverse engineer existing commercial formulations
• Liquid, sterile, and solid dose pilot-scale manufacturing
• Analytical method development and validation

GMP Scale-Up & Technology Transfer

Eramol ensures smooth technology transfer and commercial-scale production:

• Analytical method validation and process robustness testing
• Small-scale process validation before full-scale production
• Process scale-up to achieve expected manufacturing capacity
• Detailed process documentation, risk analysis, and operator training
• Commercial-scale process validation for routine production and release

Transfers, whether to local partners, new facilities, or global sites, are methodical, fully documented, and completed on schedule, ensuring successful outcomes.

De-Formulation & Characterisation

Eramol provides expert de-formulation services, enabling:

• Identification and quantification of APIs and excipients
• Reverse engineering of commercial products for generic or comparator development
• Creation of bioequivalent formulations for rapid market entry
• Support for patent expiry strategies and early generic launch

This expertise allows clients to accelerate product development while ensuring regulatory compliance.

Partner With Eramol

Eramol’s formulation development services combine scientific expertise, GMP-compliant facilities, and regulatory knowledge to deliver:

• Clinical and commercial formulations across multiple dosage forms, including sterile liquids/vials
• Placebo and comparator product development
• Analytical method development and stability testing
• Seamless scale-up and technology transfer
• De-formulation and reverse engineering for generics

Our integrated approach ensures efficient, compliant, and high-quality product development from concept to commercial launch.

Speak to Our Team

Ready to accelerate your formulation development, including sterile liquids and placebos?

Contact Eramol today to discuss your project and access expert regulatory and formulation support.