Regulatory and Quality Assurance

Navigating complex global regulatory landscapes requires expert guidance and strategic execution. APDM Pharmaceuticals has a dedicated Regulatory Affairs (RA) and Quality Assurance (QA) team, ensuring seamless approvals and compliance with evolving international regulations.

Regulatory Affairs Expertise

  • Dossier Preparation & Submission – End-to-end compilation of CTD/eCTD dossiers for worldwide submissions.
  • Global Regulatory Support – Expertise in FDA (USA), EMA (Europe), TGA (Australia), ANVISA (Brazil), MHRA (UK), and CDSCO (India) regulations.
  • GMP & Compliance Audits – Assisting in regulatory inspections, audits, and post-approval changes.
  • Lifecycle Management – Managing ANDA, NDA, DMF, and 505(b)(2) applications for continuous compliance.

Quality Assurance & Compliance

  • Data Integrity & Risk Management – Adhering to ALCOA++ principles for complete transparency.
  • cGMP, GLP, and ICH Guidelines – Ensuring strict compliance with current global pharmaceutical standards.
  • End-to-End Product Quality Control – Monitoring from raw material sourcing to final release of finished product.
With regulatory intelligence, proactive compliance strategies, and deep industry expertise, we help clients accelerate approvals, minimize risks, and maintain regulatory readiness.

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Who We Are

Founded in June 2022, APDM Pharmaceuticals was born from a bold vision by enterprising entrepreneurs and seasoned scientists to reshape the pharmaceutical landscape. With a focus on innovation, quality, and ethical partnerships, APDM quickly established ourselves as a dynamic industry force.

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