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Partnering Innovation with Quality.

Your Trusted Partner for Pharmaceutical Drug Product Research Services

We help pharmaceutical companies and healthcare organizations develop safe, effective, and high-quality drug products that improve patient lives worldwide.

About Us

Welcome to Axenza Pharma

At Axenza, we are a dedicated team of passionate scientists and professionals committed to helping pharmaceutical companies and healthcare organizations develop safe, effective, and high-quality drug products that improve patient lives worldwide.

Our multidisciplinary team includes experienced formulation and analytical scientists, quality assurance specialists, project managers, and regulatory experts. Together, we provide comprehensive research and development support across the product lifecycle.

Learn More About Us
Axenza Pharma scientists working in the laboratory

Turning Science into
Better Patient Outcomes

  • Scientific Excellence
  • Regulatory Compliance
  • Client Collaboration

Our Mission

To provide high-quality, science-driven pharmaceutical research and development services that enable our partners to bring safe, effective, and compliant drug products to market efficiently. We are committed to technical excellence, regulatory integrity, and collaborative innovation that improves patient outcomes globally.

Our Vision

To be a globally trusted pharmaceutical R&D partner, recognized for our scientific expertise, quality systems, and ability to accelerate drug product development from concept to commercialization.

Our Services

Detailed Service Offerings

Preformulation Services

Our preformulation studies provide the critical scientific foundation required for successful drug product development. We generate comprehensive physicochemical and biopharmaceutical data to support formulation design, process development, and regulatory strategy.

Our Capabilities

  • Solubility profiling across pH range
  • pKa determination
  • Partition coefficient (Log P / Log D)
  • Hygroscopicity assessment
  • Polymorphism and crystallinity evaluation
  • Salt screening and selection
  • Particle size distribution
  • Bulk and tapped density
  • Powder flow properties
  • DSC, TGA, XRPD, FTIR and Raman studies

Key Outcomes

  • Rational formulation strategy selection
  • Optimized excipient compatibility
  • Reduced development risk and cost
  • Accelerated timelines
  • Strong scientific justification for regulatory submissions
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Formulation Development

We design robust, scalable and patient-centric drug products, taking each formulation from prototype development and optimisation through to scale-up and technology transfer. Quality by Design (QbD) principles guide every stage so that the final product is stable, manufacturable and ready for regulatory review.

Our Capabilities

  • Prototype formulation design and screening
  • Drug–excipient compatibility studies
  • QbD and Design of Experiments (DoE) optimisation
  • Immediate- and modified-release systems
  • Taste masking and paediatric formulations
  • Process development and scale-up support
  • Technology transfer to manufacturing sites
  • Pharmaceutical development reports

Key Outcomes

  • Stable, manufacturable formulations
  • Clear understanding of critical quality attributes
  • Smooth scale-up and technology transfer
  • Fewer batch failures and reworks
  • Development data ready for regulatory filing
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Analytical Development

Our analytical scientists develop, validate and transfer reliable, stability-indicating methods that support every stage of development — from early characterisation to release and stability testing. All work is carried out in line with ICH guidelines and documented for regulatory submission.

Our Capabilities

  • Method development (HPLC, UPLC, GC, UV)
  • Method validation as per ICH Q2
  • Impurity and degradation product profiling
  • Dissolution method development
  • Comparative dissolution profiling
  • Residual solvent and elemental impurity assessment
  • Reference standard characterisation
  • Analytical method transfer

Key Outcomes

  • Validated, stability-indicating methods
  • Reliable release and stability data
  • Regulatory-compliant documentation
  • Faster method transfer to QC laboratories
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Stability Studies

We plan and manage stability programmes that build confidence in your product’s quality throughout its shelf life. From forced degradation to long-term ICH studies, our data supports storage conditions, packaging selection and shelf-life claims.

Our Capabilities

  • ICH long-term, intermediate and accelerated studies
  • Forced degradation (stress) studies
  • Photostability testing (ICH Q1B)
  • In-use and hold-time studies
  • Container-closure and packaging compatibility
  • Stability protocol and report preparation
  • Shelf-life estimation and trend analysis

Key Outcomes

  • Data-backed shelf-life claims
  • Early identification of stability risks
  • Clear storage and packaging recommendations
  • Submission-ready stability reports
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Regulatory Support

We translate development data into clear, well-structured regulatory documentation. Our regulatory specialists support dossier preparation, gap analysis and responses to agency queries, helping you move from development to approval with fewer delays.

Our Capabilities

  • CTD / eCTD Module 2 and Module 3 preparation
  • Pharmaceutical development (3.2.P.2) reports
  • Specification setting and justification
  • Dossier gap analysis and remediation
  • Responses to regulatory deficiency letters
  • Regulatory strategy for regulated and emerging markets

Key Outcomes

  • Review-ready, well-structured dossiers
  • Fewer agency queries
  • Shorter approval timelines
  • A clear regulatory roadmap for each product
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IP Support

Our scientists work alongside your legal and IP teams to provide the technical understanding needed for sound intellectual property decisions — from reviewing the patent landscape to designing differentiated, non-infringing formulations.

Our Capabilities

  • Technical review of patent landscapes
  • Scientific inputs for freedom-to-operate assessments
  • Non-infringing formulation design
  • Polymorph and salt-form evaluation
  • Experimental data to support patent filings
  • Technical support for patent challenges

Key Outcomes

  • Reduced infringement risk
  • Differentiated, protectable products
  • Better-informed development decisions
  • Stronger scientific support for IP positions
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Quality & Compliance

Quality is built into everything we do. Our quality assurance specialists help partners establish and maintain compliant systems — from documentation and data integrity to audit readiness — so that development work stands up to regulatory scrutiny.

Our Capabilities

  • GMP / GLP documentation and SOP development
  • Quality risk management (ICH Q9)
  • Data integrity (ALCOA+) practices
  • Audit preparation and mock inspections
  • Deviation, OOS and CAPA investigation support
  • Vendor and laboratory qualification

Key Outcomes

  • Inspection-ready quality systems
  • Consistent quality across the product lifecycle
  • Assured data integrity
  • Reduced compliance risk
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Formulation Development

Dosage Form Expertise

We develop robust, scalable, and patient-centric drug products across multiple dosage forms.

Solid Oral Dosage Forms

Solid Oral Dosage Forms

  • Immediate-release tablets & capsules
  • Modified-release formulations (ER, DR, CR)
  • High-potency and low-dose formulations
  • Taste-masked dosage forms
  • Orally disintegrating tablets (ODTs)
Liquid Dosage Forms

Liquid Dosage Forms

  • Oral solutions and suspensions
  • Pediatric and geriatric-friendly formulations
  • Solubility enhancement strategies
Semi-Solid Dosage Forms

Semi-Solid Dosage Forms

  • Creams, ointments, and gels
  • Dermatological formulations
  • Topical drug delivery systems

Let’s Accelerate Your
Drug Product Development Journey

Partner with Axenza Pharma for reliable, efficient, and customized pharmaceutical R&D solutions.

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