Biotechnology & Pharmaceuticals

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Developing innovative therapeutics requires navigating complex scientific, regulatory, and manufacturing challenges. GSAP provides integrated, end-to-end support across biologics (mAbs, biosimilars, recombinant proteins, plasma products, vaccines, and cell/gene therapies), chemical entities (small molecules, synthetic peptides, lipid-based prodrugs, and nucleic acids), RNA-based therapies (mRNA, siRNA, antisense oligonucleotides) and advanced delivery systems—guiding programs from early discovery through commercial lifecycle management.

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How We Support Biotechnology & Pharmaceutical Companies

 

  • Regulatory Strategy & Global Pathways
    Crafting phase-appropriate regulatory roadmaps, Target Product Profiles (TPPs), and global entry strategies—including early alignment via EMA Scientific Advice and FDA INTERACT/PRE-IND meetings
  • Translational & Clinical Execution
    Structuring non-clinical safety/efficacy programs, trial protocols, and clinical development plans to de-risk phase transitions and support regulatory filings—combining strategic oversight with full-service CRO capabilities, including study setup, monitoring, data management, and clinical site operations
  • CMC & Process Development
    Comprehensive Chemistry, Manufacturing, and Controls (CMC) strategy, including analytical method validation, technology transfer, process characterization, comparability and commercial manufacturing readiness
  • Regulatory Submissions & Health Authority Interactions
    Authoring and reviewing critical dossiers (IND, IMPD, NDA, BLA, MAA) and leading direct, proactive interactions with the FDA, EMA, IMOH, and national competent authorities
  • Quality Systems & GxP Compliance
    Establishing and maintaining phase-appropriate Quality Management Systems (QMS), supplier qualification programs, EU/FDA GMP compliance, data integrity frameworks, and mock inspections
  • Engineering, Qualification & Facility Validation
    Technical guidance for facility design, cleanroom qualification, EU Annex 1 compliance, equipment qualification (IQ/OQ/PQ), cleaning validation, and manufacturing infrastructure readiness.
  • Lifecycle Management & Sustaining Compliance
    Sustaining commercial viability through post-approval variation management, annual reviews, post-marketing surveillance, and continuous quality oversight