We Lead The Development Process

Regulatory approval with federal regulatory bodies is a daunting task.  For domestic and international companies alike, the ultimate goal of FDA approved drugs requires experience, high quality expertise and practices, and efficiency.  Whether you are a small or medium domestic US enterprise or a foreign-based pharmaceutical developing drugs for the US market, the drug development process, and ultimately the submittal process, becomes the bottleneck of your operations.

Roubion offers a full-range of pharmaceutical development services to meet your portfolio needs.  We specialize in regulatory application project management and submittals, development of clinical and non-clinical protocols, and co-development of pharmaceutical assets.

Roubion Pharmaceuticals has partnered with dedicated API and cGMP companies in its product development efforts.  Together, Roubion's integrated solutions include finished dosage formulation, scale-up, testing, and project management to support in-house and partner-developed technology for regulatory applications and registration filings.  Our key services and capabilities include:
Pre-Formulation/Formulation Management
  • Active impurity profile and stability
  • Potential polymorphic forms
  • Specifications
  • In-house testing development (vs supplier method and specs)
  • RLD physical, microscopic observation, analytical testing
  • Evaluation of biostudy parameters and preliminary design
  • Full chemical characterization
  • Evaluation and design of suitable manufacturing processes, including wet, dry, and slugging processes
  • Evaluation of closure systems
  • Pre-pivotal analytical evaluation

Process Qualification and Validation
  • Batch documentation, PQ protocol, and key step design
  • Process validation reports covering intra-batch and inter-batch similarity between pivotal and commercial validation lots

Process Re-Validation
  • SUPAC for CMC or minor changes
Process Optimization
  • Manufacturing optimization studies, including parameters covering granulation, drying, blending, compression
  • Development of process optimization report for the PDR

Pre-Pivotal Analytical Evaluation
  • IVIV analytical evaluations covering dissolution parameters (Level A/C)

Scale-Up Development and Pivotal Batch
  • Process design and qualification
  • Final batch documentation and operating monitoring

Pre-Submission/Submission
  • All development report, regulatory file (ANDA), SOPs, biostudy report, and validation
  • Full submission and filing
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In addition, Roubion is seeking dedicated-partners with cGMP-capabilities and FDA-site-inspected facilities to co-develop a pharmaceutical portfolio.  Roubion is currently in formulation and analytical testing phases and has developed a full quality by design plan.  We are particularly interested in strategic partners with solid-dose, sterile, and/or liquid manufacturing capabilities.  Please contact us for more information.