Magellan Pharmaceutics offers comprehensive product/dosage form development services, including API candidate screening/characterization, preformulation, excipient compatibility, toxicology formulations, product formulation, manufacture of GMP clinical supplies, and clinical packaging, labeling and distribution. Our pharmaceutical development team has experience with small and large (biotechnology) molecules, including highly potent candidates and a variety of dosage forms. Our team has years of pharmaceutical industry experience, including a successful record of regulatory submissions and approvals.

Other services include: salt screening/selection, polymorph screening, analytical development and validation, comparator development, and cleaning/process validation.

Magellan Pharmaceutical Development has built a reputation as the premier contract pharmaceutical development organization that builds long-term relationships based on excellent communication, timeliness and delivering quality science to its clients.

Magellan Pharmaceutical Development can help accelerate your pharmaceutical development efforts by providing immediate resourcing and technical expertise in support of your product.

Please give us a call with any questions or submit a project to us online for a project proposal!

Magellan Capabilities

• Candidate Screening/Preformulation
  • Pharmaceutical Synthesis/Isolation/GMP Manufacture
  • Metabolic Profiling
  • In-vitro Transport
  • Solution and Solid State Stability
  • pH-rate profile
  • pKa(s)/Ionization state
  • Polymorphism
  • Solubility - polar/non-polar, pH-solubility profile
  • pH Partition Coefficient
  • Particle Size/Shape/Distribution
  • Solid state characterization
    Thermal Analysis (DSC, TGA)
    IR
    Particle size/shape/distribution
    Intrinsic Dissolution
• Toxicology Formulations
  • Powder in a Bottle
  • Solutions/Suspensions
  • API/Blend in a Capsule
• Excipient Compatability
• Formulation Development (NCEs/Line-Extensions)
  • Tablets (IR, SR, Coated)
  • Capsules
  • Liquids (syrups, suspensions, solutions)
  • Topicals (creams, ointments, gels, lotions)
  • Parenterals / Injectables
  • Inhalation (MDI, DPI, Nasal sprays, Nebulizing solutions)
  • Dissolution
  • Cleaning Assay Development and Validation
  • Process Validation
• GMP Clinical Supplies
  • GMP API Manufacture
  • First-in-Man study supplies
  • Dosage form Manufacture
  • Comparator Development, including Over-Encapsulation
  • Placebo Manufacture
  • Cleaning Verification
• Clinical Supplies Packaging
  • Packaging and labeling
  • Storage and Distribution
  • Returns and Destruction

Services Offered By Magellan

• Analytical Testing
• Bioanalysis
• Biotechnology
• Clinical Packaging
• Compendial Analysis
• Drug Discovery & Bioassays
• Drug Substance Testing
• Inhalation Product Development
• Method Development and Validation
• Microbiology
• Pharmaceutical Synthesis
• Pharmaceutical Validation
• Pharmaceutics
• Quality Assurance Consulting
• Regulatory Affairs
• Stability Storage
• Stability Testing
• Structural Chemistry