Consultancy

Given the complexity of drug development, it’s very important to examine opportunities and challenges from every angle — assurance and advisory, risk management, strategy planning, technology development and cost containment— and that’s just what we are positioned to help our clients achieve. The process of developing therapeutic drug product is an information intensive endeavor. Companies face an enormous challenge in complying with ever changing government agency regulations as well as finding new ways of reducing drug development costs and introducing products in a timely manner. CuriRx is positioned to help by working together with companies in addressing these challenges. We help organizations build value by uncovering insights by gap analysis that helps to improve performance. We provide our clients with world-class insights that generate tangible and measurable impact. We help clients redefine the vision for their company, restructure for a long-term and sustainable change, or build specific strategic and tactical capabilities to accomplish their product development objectives. We work under the leadership of a lead client service partner to help businesses uncover opportunities and manage risks.

Our consulting portfolio enhances our ability to help clients improve their analytical, formulation, product development, including streamlining Quality Assurance and develop standard operating procedures for all therapeutic molecules including biosimilars.

For Product Development we provide variety of consulting depending upon the stage and requirement, either to set up the experiments, process optimization and improvement or provide Gap Analysis to predict development challenges for effectively advancing drug development. Our understanding of the growing regulatory pressures that companies experience allows us to help clients thoughtfully navigate towards the next milestone while managing costs and program execution effectively.

  • Process design , development and validation protocols
  • Process improvement/Optimization and Troubleshooting
  • Cell Culture optimization strategies
  • Protein Purification process development
  • The chemistry, manufacturing and controls sections of regulatory submissions

An effective quality system is critical for regulatory approvals. Our quality consultancy offering includes development of quality manuals and policies, standard operating procedures (SOPs), work instructions, quality assurance (QA) processes, and training and regulatory inspection readiness programs. For cGMP manufacturing, we help you maintain FDA-compliant facilities and produce safe and effective product.

Our areas of expertise include:

  • Quality System strategies – High level initial assessments and strategy for developing and optimizing complete QA systems
  • Quality and compliance gap analysis and remediation
  • Quality Investigations and Root Cause Analysis
  • Vendor/supplier qualification and management program
  • Quality Metrics development and implementation
  • CMO selection, management, oversight & Person-in-Plant Support
  • Batch Record Development and review
  • Environmental Monitoring Programs
  • Consultancy services on the chemistry, manufacturing and controls sections of regulatory submissions
  • Technology Transfer and/or Scale-up; Review process and adapt to appropriate equipment
  • Stability Program management
  • Validation review (IQ/OQ/PQ, Cleaning Validation, Process Validation)
  • Contract laboratory selection and management
  • Technical Representation; serve as your company's technical representative when dealing with contract manufacturing facilities

Investors provide research and development funding, oversight, and mentorship to companies in the life sciences. We can help provide operational support for their portfolio companies through:

  • Due diligence, Strategic plans and Organizational structure design and optimization
  • Product Development Strategy, Milestone definition and timeline planning
  • Quality systems
  • Resource allocation, Roles and responsibilities
  • Business Requirements Analysis
  • Vendor Identification, selection and RFP development
  • Relationship Management
  • Provide due diligence consultancy services to review the CMC section of the product dossier for those clients wishing to in-license a product