Our Services

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Our platform leverages data analysis to provide expert guidance on navigating the complex regulatory landscape for rare diseases worldwide.

• Developing strategies for Orphan Drug Designation (ODD) and expedited pathways (Fast Track, BTD, RMAT).
• Transforming fragmented RWD to targeted RWE.
• Aligning with requirements of global agencies (eg FDA/EMA).

We provide RWE clinical development services for rare disease research, addressing challenges like small patient populations.

• Strategic and adaptive trial design and endpoint selection.
• Strategizing trial extent based upon available RWE
• Aiding in the identification and recruitment of diverse and underserved subjects.

We support the establishment of efficient, phase-appropriate **Quality Management Systems (QMS)** compliant with global standards.

• Compliance with cGMP, ISO 13485, and ISO 9001.
• Tailored services for complex rare disease manufacturing and supply chains.
• Low-cost support for independent audits and site readiness.

We provide strategic Chemistry, Manufacturing, and Controls (CMC) oversight from discovery through commercialization.

• Phase-appropriate CMC strategy (IND/BLA/NDA) development.
• Analytical method development and validation.
• Manufacturing process scale-up and validation.
• Supply chain and external partner (CMO/CRO) management.

Expert support to address critical compliance issues and ensure the broadest possible patient access globally.

• Response to agency concerns and Warning Letters.
• Global supply chain compliance.
• Specialized certifications: Halal, Kosher, and Animal-Origin Free.

Targeted regulatory and quality support for medical technologies crucial for rare disease management and treatment.

• Support for AI-driven Software as a Medical Device (SaMD).
• Navigating FDA , MDSAP, and EU MDR/IVDR requirements.
• Compliance for ISO 13485, MDSAP, ISO 14971 (Risk Management) and ISO 10993 (Biocompatibility).