The Intelligence Layer for Global Life Sciences
Aventiq Bio serves as the strategic technical proxy for global VPs of R&D, Procurement, Quality, and Program Leadership.
Independent Governance Across the Full Spectrum of Molecular Complexity.
Focus: Innovative Chemistry & High-Potency Containment
NCE Governance: End-to-end oversight for New Chemical Entities from lead to GMP scale.
DAR & Kinetic Stability: Independent verification of Drug-to-Antibody Ratios and systemic safety.: Expert management of cytotoxic/hormonal compounds (OEB 4/5/6).
Complex Peptides & Oligos: Technical advisory for long-chain synthesis and advanced purification.
Focus: Biological Fidelity & Bio-equivalence
mAbs & Proteins: Strategic oversight of cell line stability and bioreactor productivity.
Biosimilars & Vaccines: QbD-driven governance for mRNA, viral vectors, and protein subunits.
Analytical Characterization: : Deep-dive oversight of folding, glycosylation, and purity profiles.
Focus: The Interface Guard (Integrated Technical Oversight)
ADC Excellence: Managing the intersection of payloads, complex linkers, and mAbs.
PDCs & RDCs: Specialist governance for Peptide and Radiopharmaceutical conjugates.
DAR & Kinetic Stability: Independent verification of Drug-to-Antibody Ratios and systemic safety.
Focus: The Frontier of Genomic Innovation
Cell & Gene Therapy (CGT): Technical oversight for AAV/LV integrity and CAR-T workflows.
Genomics & Precision Medicine: Supporting biomarker-driven data integrity and personalized platforms.
Nucleic Acid Therapies: Expert navigation of siRNA, ASO, and CRISPR manufacturing hurdles.
De-risking the journey from In Silico Discovery to GMP Commercialization.
Transforming data into defensible leads with computational and genomic foresight.
In Silico & Computational Chemistry Advisory:
AI-driven molecular docking, virtual screening, and predictive ADME/Tox to de-risk capital allocation pre-synthesis.
Discovery & Medicinal Chemistry:
Hit-to-lead (H2L), SAR studies, and scaffold hopping to strengthen non-infringing IP portfolios for both Small Molecules and Complex Peptides.
Discovery Biology & Screening:
Independent vetting of labs for assay reproducibility to eliminate systemic discovery failure in High-Potency and Large Molecule programs.
Genomic Target Identification:
Specialized oversight for Precision Medicine platforms, ensuring data integrity in biomarker discovery and genetic target validation.
Ensuring technical fidelity across complex synthetic and biological modalities.
Process Chemistry & Route Development:
Design of cost-effective, ESG-compliant ("Green") synthetic routes and impurity profiling for HPAPI (OEB 4/5/6) and Nucleic Acid Therapies.
CMC & Formulation Excellence:
Solubility enhancement for BCS Class II/IV molecules and conjugation stability for ADCs, PDCs, and RDCs.
Advanced Modality Scale-up:
Technical governance for mAbs, Recombinant Proteins, and mRNA platforms, focusing on cell-line fidelity and analytical biosimilarity (QbD).
Preclinical & IND-Enabling Oversight:
Management of GLP-compliant toxicology and bioanalytical packages engineered for FDA/EMA/PMDA acceptance.
Navigating the "Last Mile" to market with absolute data integrity.
Clinical Trials & Bioanalytical Oversight:
Site selection and monitoring for BA/BE and Phase I/II studies, specializing in Cold-Chain logistics for Cell & Gene Therapy (CGT).
Regulatory & Quality Advisory:
eCTD dossier preparation, ALCOA+ data integrity audits, and mock inspections for global compliance.
Precision Medicine Access:
Advisory on Companion Diagnostics (CDx) and genomic data governance for targeted oncology frontiers.
Virtual COO Services:
Serving as your dedicated Asia operations lead for milestone tracking and multi-vendor coordination.
Focus:
The Frontier of Genomic Innovation
Cell & Gene Therapy (CGT):
Technical oversight for AAV/LV integrity and CAR-T workflows.
Genomics & Precision Medicine:
Supporting biomarker-driven data integrity and personalized platforms.
Nucleic Acid Therapies:
Expert navigation of siRNA, ASO, and CRISPR manufacturing hurdles.
The "Premium" Call-outs
This section targets your most critical client pain points with high-revenue solutions.
Independent audit and turnaround of troubled CRO/CDMO relationships or stalled development programs. We provide rapid diagnosis, corrective action plans (CAPA), and project re-baselining to save critical timelines.
Trategic oversight from lead optimization through IND filing. We provide single-point accountability for multi-partner programs, delivering a regulatory-ready data package on aggressive, predictable timelines.
Ensuring absolute IP security during cross-border transfers. We act as your technical firewall, documenting "know-how" and verifying that proprietary processes remain your exclusive asset.
Developing "Plan B" resilience. We pre-qualify secondary sources for critical intermediates or APIs, ensuring zero disruption to your commercial or clinical supply chain.
The Aventiq Standard: We bridge the gap from R&D to Market Entry, applying pharmaceutical-grade rigor to ensure your product survives global regulatory scrutiny.
• R&D & Prototype Design: Technical oversight of Design History Files (DHF) and ISO 14971 risk management integration.
• Preclinical Safety (Large Animal Studies): Management of specialized animal safety and performance studies in large animal models (porcine/canine/sheep) as required for CDSCO and FDA pathways.
• Clinical & Biocompatibility: Oversight of human clinical investigations and ISO 10993 biocompatibility testing.
• Regulatory & Quality Ops: Turnkey ISO 13485 audits, 510(k)/PMA dossier preparation, and post-market clinical follow-up (PMCF).
R&D & Formulation: Enhancing bioavailability via SEDDS, liposomal, and nano-delivery systems; oversight of botanical DNA barcoding.
Safety & GLP Studies: Full management of safety assessments (Acute/Sub-chronic) to meet EFSA, GRAS (US FDA), and FSSAI safety standards.
Clinical Efficacy (Human Intervention): Design and monitoring of Randomized Controlled Trials (RCTs) to substantiating "High-Margin" health claims.
Post-Market Governance: Implementation of Nutrivigilance systems and stability monitoring to defend premium market positioning.
Formulation & Innovation: R&D oversight for "Clean Beauty" and bioactive integration (Peptides/Stem Cells).
Safety Substantiation: Management of scientific safety files required by US MoCRA and EU Cosmetic Regulations, including microbial and sensitization testing.
Clinical Proof (Human Studies): Oversight of dermatological clinical trials for anti-aging, acne-reduction, and microbiome-friendly claims.
Market Entry (Korea/Japan/Global): Specialized "Entry-to-Shelf" advisory for K-Beauty/J-Beauty brands entering India—covering CDSCO registration, local manufacturing vetting, and retail-ready quality control.
R&D & Tech Transfer: Development of veterinary biologicals and drug products following VICH GL60 (GMP for APIs) and GLP standards.
Safety & Residue Studies: Management of Target Animal Safety (TAS) and residue depletion trials to establish global "Withdrawal Periods" for food-producing animals.
Clinical Field Trials: Oversight of large-scale veterinary clinical trials in livestock (cattle, poultry) and companion animals (dogs, cats) to meet US FDA CVM and EMA CVMP standards.
Manufacturing & Export: Independent site governance ensuring zero cross-contamination and global regulatory-ready batch records.
Discovery & Design: Computational route optimization and custom synthesis of AI-designed active ingredients.
Preclinical & Safety: Management of GLP-compliant toxicology, eco-toxicity, and residue studies required for EPA, EU REACH, and PMFA filings.
Clinical & Field Research: Oversight of multi-location field trials and efficacy testing across diverse soil and climatic zones in India.
Manufacturing & Market Access: Tech transfer, independent site audits, and "Person-in-Plant" representation to secure the supply chain for global export.