Navigating the complex landscape of regulatory requirements is crucial for successful clinical trials, and Usahihi Therapeutics excels in this area. We manage regulatory submissions, preparing applications for Investigational New Drug (IND), New Drug Applications (NDA), and Biologics License Applications (BLA) to regulatory agencies like the FDA and EMA. Our commitment to compliance includes adhering to Good Clinical Practice (GCP) standards and conducting regular inspections and audits to ensure regulatory alignment. We also focus on pharmacovigilance, maintaining safety monitoring and reporting throughout the lifecycle of a product.
Compliance & Reporting:
- Regulatory Submissions – Preparing and submitting IND, New Drug Application (NDA), Biologics License Application (BLA), or equivalent.
- Compliance with GCP (Good Clinical Practice) – Adhering to global clinical trial regulations (FDA, EMA, MHRA, etc.).
- Inspections & Audits – Conducting internal and external compliance audits to prevent regulatory violations.
- Pharmacovigilance & Safety Reporting – Maintaining ongoing safety monitoring and post-market reporting.
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Contact Usahihi Therapeutics today to leverage our advanced services in clinical trials and therapeutic development. Start the conversation now and turn your idea into impact. Link to Contact Us page