Independent CRO/CDMO scouting and partner qualification aligned to modality and regulatory pathway
Aventiq Bio delivers independent, on-ground technical governance across India’s most regulated and high-risk life sciences sectors.
While execution challenges vary by industry, the failure modes are consistent: partner misalignment, data integrity gaps, regulatory drift, and late-stage surprises.
Our role is to intervene before those failures occur-with senior-led governance, continuous intelligence, and defensible decision-making that protects regulatory outcomes, timelines, and enterprise value.
Lifecycle Coverage: Aventiq governance spans discovery, preclinical, CMC, GMP manufacturing, and clinical readiness-remaining engaged until regulatory and commercial risk is materially reduced.
Independent CRO/CDMO scouting and partner qualification aligned to modality and regulatory pathway
On-ground technical, quality, and compliance audits aligned with US FDA, EMA, and global expectations.
Program governance during tech transfer, scale-up, and execution, enforcing ALCOA+ data integrity.
Continuous Intelligence™-AI-assisted early-warning signals validated by senior experts and on-ground teams.
Program stabilization and rescue when timelines, quality, or inspection readiness are at risk.
Governance decisions are human-led and decision-accountable, made by 20+ year CRO/CDMO veterans, subject-matter experts, and qualified auditors, and supported by competitive intelligence-not databases or junior analysts.
Small molecules (NCEs & generics) • HPAPIs • Peptides & oligonucleotides • ADCs • Biologics & biosimilars • Cell & Gene Therapy • Vaccines • Precision medicine & companion diagnostics.
Independent scouting and qualification of CDMOs and CROs for ADCs, CGT, biologics, and complex small molecules.
On-ground technical, quality, and compliance audits aligned with FDA and EMA expectations.
Governance of tech transfer, process scale-up, and CMC readiness, including ALCOA+ data integrity enforcement.
Continuous oversight and program rescue when execution or inspection readiness is at risk.
Outcome:
Confident, well-documented partner selection; globally defensible data packages; predictable execution; and materially reduced FDA/EMA inspection risk.
Qualification of device manufacturers, testing laboratories, and software partners
On-site ISO 13485 and design-transfer audits
Governance of supplier interfaces across hardware, software, and chemistry
Outcome :
Defensible supplier selection, audit-ready technical files, and reduced 510(k) / MDR clearance risk.
Vetting of ingredient suppliers and formulation partners
Governance of stability, batch consistency, and claims substantiation
Independent third-party testing oversight for global markets.
Outcome:
Verified manufacturing partners, stable product performance, and defensible global claims.
Supply-chain transparency audits and ingredient traceability verification
Governance of efficacy, safety, and regulatory documentation
Alignment with EU and US retail compliance expectations.
Outcome:
Protected brand reputation and predictable entry into stringent global markets.
Modality Coverage:
Veterinary APIs • Vaccines • Feed additives • Parasiticides
Qualification of veterinary API, vaccine, and formulation partners
Oversight of species-specific formulation integrity and manufacturing controls
Governance aligned with global veterinary regulatory expectations.
Outcome:
Confident partner selection, scalable manufacturing, and predictable regulatory timelines.
Modality Coverage:
Crop protection actives • Intermediates • Formulations
Independent vetting of synthesis and formulation CDMOs
Governance of impurity profiling, scale-up, and waste-stream compliance
Oversight of export-readiness and international toxicology standards.
Outcome:
Stable supply chains, compliant manufacturing, and export-ready operations.
Programs are led by experienced CRO/CDMO professionals and qualified auditors—not junior consultants
AI-assisted risk signals combined with on-ground validation and competitive intelligence
No labs, no manufacturing assets, no vendor commissions
Every partner selection and program decision is documented, auditable, and board-safe
Your science deserves an unbiased guardian.
In an outsourcing landscape where many "advisors" accept hidden referral fees or "success commissions" from the very vendors they recommend, Aventiq Bio stands in total opposition. We are a Technical Fiduciary. Our loyalty is not to the vendor ecosystem—it is exclusively to your program’s success and the integrity of your data.
We never accept "kickbacks," referral fees, or incentives from CROs, CDMOs, or laboratories. Our only source of compensation is our clients.
We own no laboratories, manufacturing plants, or clinics. Because we have no "idle capacity" to fill, our technical audits remain 100% objective.
We act as your scientific proxy. We only approve technical milestones when the data is objectively "submission-ready," not when a vendor needs to trigger a payment.
Our clients see the original, un-marked-up quotes from Indian vendors. We price on the value of our Governance, not on the volume of your spend.