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Marelius® Biopharma Group Ltd

Biopharma | Regulatory | Clinical Services

About Us

Marelius® Biopharma Group Ltd is a specialist biopharmaceutical and life-sciences organisation providing regulatory, clinical, and strategic support to biotechnology and therapeutics programmes operating in highly regulated environments.

Strategic Support

Comprehensive guidance across regulatory strategy, clinical development, and international execution, helping programmes progress efficiently from early development.

Global Execution

Evidence-based strategies and cross-border operational capabilities that support market-facing stages across multiple international jurisdictions.

Scientific Depth

Collaborating closely with sponsors, investigators, and regulatory authorities to combine scientific rigor with commercial insight.

Marelius® Biopharma Group Ltd operates within the Marelius group, which includes Marelius Inc. (OTCID: MBPG), a publicly traded life-sciences company.

Regulatory Expertise

Deep experience across major regulatory frameworks

FDA U.S. Food & Drug Administration IND · NDA · BLA Filings
EMA European Medicines Agency IMPD · MAA Procedures
MHRA UK Medicines Regulator UKCA · Post-Brexit Strategy
DEA Drug Enforcement Administration Controlled Substances

Core Capabilities

Manufacturing

Manufacturing Services

Specialised contract manufacturing support for the biopharmaceutical industry.

  • Small-Scale Contract Manufacturing
  • GMP Compliance (FDA, EMA, MHRA)
  • Advanced Technology & Equipment
Training

Professional Training

Elevating standards through comprehensive education and hands-on GMP workshops.

  • Online Regulatory Courses
  • In-Person GMP Facilities
  • Tailored Corporate Training Solutions
Regulatory Pathways

Advanced Regulatory Pathways

Navigating regulatory ambiguity in 'High-Trust' nodes.

  • Senior-led strategy for Early Clinical Design
  • IND/IMPD filings management
  • Cross-border licensing (DEA/MHRA) for complex frontiers
Venture Advisory

Venture Advisory & Equity

Moving beyond the fee-for-service model to align with long-term outcomes.

  • Advisory contracts linked to equity
  • Capital deployment for Cell & Gene / CNS
  • Shared-risk commercial models

Operational Focus

Marelius® Biopharma Group Ltd continues to support biotechnology and therapeutics programmes through regulatory strategy, clinical development support, and international execution. The company operates as part of the Marelius group, which includes Marelius Inc. (OTC: MBPG), and works with sponsors, investigators, and strategic partners across regulated healthcare environments.

Leadership

Dr Abel N. J. Haque

Dr Abel N. J. Haque

B.Med Sci (Hons), BM BS

Dr Haque leads Marelius® Biopharma Group Ltd with over 35 years of international experience in healthcare, biotechnology, and life sciences. His career includes senior executive roles at Stryker Corporation (NYSE: SYK) and Wright Medical Group (NASDAQ: WMGI), and he currently serves as CEO of Marelius Inc. (OTCID: MBPG).

Dr Haque's leadership combines clinical insight with deep regulatory and commercial expertise, managing teams and consultants to support clients through complex development pathways across FDA, EMA, and MHRA jurisdictions.

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