Consultation for Existing/New Drug Substance & Drug Product Developments

Introduction

At Chalcogen Pharma, we offer comprehensive consultation services for the development of new and existing drug substances and drug products. Our expert team provides strategic guidance and technical expertise to ensure efficient product development, regulatory compliance, and successful commercialization. Whether you are formulating a novel drug or optimizing an existing product, our tailored solutions cater to your specific requirements.

Our Expertise

  1. Pre-Formulation & Formulation Development: Scientific assessment of drug properties and formulation strategies for enhanced efficacy and stability.
  2. Process Development & Optimization: Designing scalable and reproducible manufacturing processes to ensure product consistency.
  3. Analytical Development & Validation: Developing robust analytical methods to support product characterization and quality control.
  4. Regulatory Strategy & Compliance: Providing end-to-end support for IND, NDA, ANDA, and DMF submissions.
  5. Technology Transfer & Scale-Up Support: Ensuring seamless transition from laboratory to pilot and commercial-scale manufacturing.
  6. Lifecycle Management & Product Enhancement: Improving existing formulations for better bioavailability, stability, and patient compliance.
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Key Services We Offer

  1. Drug Substance Development (Synthetic & Biotechnological Pathways)

  2. Drug Product Formulation (Oral, Injectable, Topical, & Inhalation Dosage Forms)

  3. Stability Studies & Shelf-Life Assessment

  4. Excipient & Compatibility Studies

  5. Impurity Profiling & Risk Assessment

  6. Bioequivalence & Pharmacokinetic Studies

  7. Quality by Design (QbD) & Risk-Based Approach Implementation

  8. Regulatory Gap Analysis & Dossier Preparation

At Chalcogen Pharma, we are committed to accelerating the development of safe, effective, and high-quality drug substances and drug products. Get in touch with us today to discuss your project and explore how we can support your pharmaceutical development journey!