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Solutions for the US

Achieve success for your product’s development in the US, align across global regions, and leverage effective communication with FDA as your partner.

What are the challenges for companies developing HealthTech products for the US market?

  • Limited experience interacting with the FDA, and unfamiliar with the complex regulatory environment in the US and the FDA’s requirements.
  • Uncertain about the regulatory pathway.​
  • The need to engage with FDA optimizing procedures to optimize product development.

How can VCLS help?

Lead regulatory department with long-term partnership

  • Provide regulatory strategy as US/Regulatory Agent across all stages of development and FDA divisions.
  • Prepare, submit and participate/lead in Initial Targeted Engagement for Regulatory Advice on CBER/CDER Products (INTERACT), pre-IND, Types A, B, C and D, FDA meetings and all communications.
  • Prepare/Review Regulatory submissions such as IND/NDA/BLA/ANDA/DMFs, VMFs, Controlled Correspondence.

Proven record on FDA expedited programs 

  • Assess, prepare and request expedited programs offered by the FDA, including Regenerative Medicine Advance Therapy Designation (RMAT), Fast-track Designation (FTD), Breakthrough Therapy Designation (BTD), Accelerated Approval (AA) and Priority Review (PR).

Full clinical research services 

  • Author patient-centric protocol(s).
  • Study monitoring and management.
  • Build a scalable safety system, oversee and manage the clinical assessment.
  • Provide Pharmacovigilance Support.

Streamlined lifecycle management

  • Regulatory maintenance and compliance, including protocol and information amendments, supplements (CBEs/PAS), Annual Reports (IND, DSUR, NDA, BLA, PADER, PSUR, DMF, VMF, ODD) and labeling updates.
  • Electronic Drug Registration and Listing System (eDRLS) support and Drug Distribution reporting persuant to CARES Act.
  • PMC support.
  • IND Safety Reports.
  • Field Alerts.

VCLS Solutions