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Regulatory Intelligence

Regulatory Consulting

Strategic regulatory pathways for pharmaceuticals, biotechnology, and APIs. We navigate global submission complexities to ensure seamless compliance and market access.

eCTD Expertise

Agency Liaison

Submission Strategy

NDA / MAA / ANDA Review
DMF Compilation (CTD)
Medical Device 510(k)
Compliance Excellence

Navigating Global
Submission Standards

Abiozen offers high-level regulatory consultation services tailored to the specific needs of pharmaceutical and biotech manufacturers. Our expertise ensures that your product registration dossiers are meticulously reviewed and compiled.

"From initial IND/CTA submissions to full Lifecycle Management, we serve as your direct liaison with global regulatory agencies."

eCTD Expertise
Agency Liaison
GMP Services
Import/Export

Our Regulatory Services

Comprehensive support for pharmaceuticals, biotechnology, and medical devices.

Dossiers & Submission Filings

  • eCTD Submissions: Compilation and submission for IND/CTA, NDA/MAA, and ANDA.
  • Product Registration: Specialized dossier review for NDA/MAA, ANDA, and DMF.
  • Device Submissions: Specialized 510(k) and PMA submissions for medical devices.
  • DMF Management: DMF compilation for EU and USFDA in full CTD format.

Lifecycle & Compliance

  • Annual Management: Maintenance of variations, renewals, and safety reports.
  • Regulatory Responses: Strategic review and responses to regulatory deficiencies.
  • GMP Compliance: Facilities services for APIs and finished product manufacturing.
  • Liaison Support: Expert T-License, Import, and Export dossier preparation.