Drug Product Development and Manufacturing Support

• We offer specialized, hands-on support for the development of complex drug products, including oral solid dosage forms and sterile injectables (SVPs and LVPs). Our approach ensures:

  • Tailored formulation strategies based on product-specific challenges

  • Efficient interpretation of R&D data to accelerate development timelines

  • Enhanced product robustness and manufacturability

Formulation Development

Drug Product Categories by Manufacturing Technology

• Our expertise spans a wide range of manufacturing technologies, enabling flexible and scalable solutions:

  • Aseptic Manufacturing: Vials, Cartridges, Prefilled Syringes, IV Bags

  • Terminal Sterilization: Vials, Ampoules, IV Bags

  • Lyophilization

  • Granulation Techniques: Rapid Mixer, Fluidized Bed, Melt Granulation, Extrusion Spheronization, Powder Layering

  • Pelletization: Wurster Process, Powder Layering

  • Compression: Direct Compression, Complex Blends, Multi-Unit Particulate Systems

  • Encapsulation: Hard and Soft Gelatin, HPMC Capsules

  • Coating: Functional and Non-Functional

  • Spray Drying

Drug Product Categories by Drug Release Mechanism

• We support development across various release profiles to meet therapeutic needs:

  • Parenteral Solutions and Suspensions

  • Immediate Release Formulations (Tablets, Capsules, Sachets)

  • Modified Release Formulations (Tablets, Capsules, Sachets)

  • Powder for Oral Suspensions (PFOS)

Bioequivalence Candidate Selection

• In-vitro data analysis of reference and test products

• Identification of optimal candidates for pilot and pivotal studies

Technology Transfer and Documentation

• We ensure seamless tech transfer through comprehensive documentation:

  • Tech Transfer Document Preparation

  • Stability Protocol Design (Routine and Special)

  • Manufacturing Process Transfer Protocols

  • Batch Record Creation (Manufacturing and Packaging)

  • Shipping Protocol Development

  • Batch Planning and Rationalization Support

Scale-Up and Registration Batch Manufacturing

• Execution of scale-up and registration batches

• Manufacturing process troubleshooting

• Investigation and resolution of process deviations