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OSD Consulting Services

1. Process Development & Optimization

 

  • ​​​Manufacturing Processes: Advising on the selection of appropriate manufacturing precesses, such as direct compression, wet granulation, dry granulation, and extrusion-spheronization.

 

  • Process Scale-up: Assisting with scaling up the process from lab-scale to commercial-scale production, ensuring product quality, consistency, and cost-effectiveness.

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  • Technology Transfer: Supporting the transfer of the manufacturing process from R&D or pilot plants to full-scale manufacturing facilities while maintaining product quality and compliance.

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2. Regulatory Affairs & Compliance

 

  • ​​​Regulatory Submissions: Assisting with regulatory submissions for OSD products, including New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Biologics License Applications (BLAs) to agencies like the FDA, EMA, and other international bodies.

 

  • Compliance with GMP: Ensuring that the manufacturing process adheres to Good Manufacturing Practices (GMP) and other industry standards to ensure product safety and quality.

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  • Regulatory Strategy: Helping clients navigate the regulatory requirements for clinical trials, product approval, and post-marketing surveillance, specifically for oral solid dosage forms. 

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3. Clinical Trial Support

 

  • ​​​Bioequivalence Studies: Designing and supporting bioequivalence studies for generics to ensure that they are therapeutically equivalent to the branded version of the drug.

 

  • Clinical Trial Material Production: Assisting in the production of clinical trial materials, ensuring that clinical supplies are consistent, compliant, and meet regulatory requirements.

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4. Quality Control and Assurance

 

  • ​​​Stability Testing: Consulting on stability studies to assess the shelf life of oral solid dosage forms, determining proper storage conditions and expiration dates.

 

  • Analytical Testing: Providing guidance on methods for testing the quality, potency, and purity of the final product, including dissolution, assay, impurity testing, and contents uniformity.

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  • Validation: Advising on the validation of manufacturing processes, cleaning procedures, and analytical methods to ensure that products meet regulatory and quality standards. 

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5. Manufacturing and Scale-up Support

 

  • ​​​Outsourcing Manufacturing: Helping companies choose contract manufacturers (CMOs) that specialize in oral solid dosage forms and guiding the oversight of manufacturing processes.

 

  • Facility Design and Optimization: Offering advice on the design or optimization of manufacturing facilities for oral solid dosage forms, focusing on efficiency, compliance, and cost-effectiveness.

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  • Process Validation: Supporting the validation of processes and equipment used in OSD production to ensure product quality and regulatory compliance. 

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6. Packaging and Labeling

 

  • ​​​Packaging Design: Advising on the design of packaging that ensures product integrity, ease of use, and regulatory compliance.

 

  • Labeling Compliance: Helping with the creation of labels that comply with regulatory requirements and provide clear, accurate information to consumers and healthcare providers.

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