PHASILIGENCE CONSULTING

Phase-appropriate CMC strategy & Diligence

Biologics Manufacturing | CMC Analytics & Characterisation | CDMO Selection & Oversight

About
phasiligence

Phase-appropriate CMC development

Phasiligence partners with small biotech companies and established biopharma players to deliver phase-appropriate CMC strategies aligned with ICH, FDA, and EMA guidelines and integrates risk and science based Quality by Design (QbD) and Analytical Quality by Design (AQbD) principles to balance cost, quality, and delivery timelines.Our core expertise includes upstream process development, phase-appropriate assay development, method transfer to internal or external QC labs for GMP release and stability testing, reference standard manufacture, qualification, and management, product characterisation, comparability studies, technology transfer, Module 3 (Quality) authoring, and CDMO selection and oversight.Phasiligence works collaboratively with clients to deliver practical, scientifically rigorous CMC solutions that are tailored to the maturity and objectives of each development program.

Services

Phasiligence provides flexible CMC consulting strategy and execution services through short-term engagements, ongoing advisory support, and fractional leadership across all stages of biologics development—from IND-enabling studies through to BLA readiness.

01.

CMC Analytical Sciences

  • ICH Q2 and ICH Q14 (AQbD) based method development and validation.

  • Product Comparability studies

  • Product Characterisation

  • Impurity Characterisation

  • Method transfers

  • Stability testing strategy

02.

Process Development

  • Cell line development

  • Clone screening and selectiom

  • Upstream process development support

  • Formulation development support

  • Downstream development support

  • Tech Transfer

03.

Manufacturing

  • DS and DP GMP manufacturing and supply

  • GMP release and stability testing

  • FDA, EMA and ICH compliance

  • Reference standard manufacture, qualification and management

04.

CMC strategy

  • Phase appropriate CMC strategy

  • QbD based product development

  • Specification setting

  • Justification of specifications

  • OOS investigation

  • Module 3 authoring support

  • Root cause analysis

  • Change controls and impact assessment

05.

CDMO strategy and oversight

  • CDMO selection

  • Technical oversight

  • Collaborative Management

  • Data analysis and integration using Python, JMP, and other analytical tools for cross-functional and regulatory insights

06.

CMC Project Leadership

  • Cross-functional project management

  • Risk and science based decision making

  • Budget and schedule management

  • Stakeholder management

  • Responsible AI use and prompt engineering

Why Phasiligence ?

Phasiligence is led by Dr. Anurag Parihar, PMP, who has more than a decade of experience in biologics development across early- and late-stage programs for big pharma, small biotech and biosimilar companies. Dr. Parihar has contributed to the development of CMC strategies supporting multiple IND and BLA submissions, working collaboratively with cross-functional teams across, R&D, Manufacturing, Quality, Regulatory, Clinical, Non-Clinical, Commercial, IP and Legal functions.This breadth of experience enables Phasiligence to bridge scientific, technical, operational, and regulatory perspectives, providing practical, phase-appropriate CMC advice that supports informed decision-making throughout the product development lifecycle.

01.

De-risking complex science

More than a decade of biologics CMC experience spanning early- and late-stage development.

02.

Phase-Appropriate thinking

Tailored strategies aligned with program maturity, regulatory expectations, and business objectives.

03.

Collaborative CDMO management

Strategic CDMO selection and program leadership for integrated delivery of CMC activities.

Contact

Let's discuss your CMC strategy!Whether you're preparing for an IND, advancing through clinical development, addressing complex analytical challenge or strengthening your analytical and manufacturing strategy for BLA readiness, Phasiligence provides practical, phase-appropriate CMC expertise tailored to your program.

Based in Melbourne, Australia and available to support clients across Australia and internationally.

© 2026 Phasiligence Consulting Pty Ltd . All rights reserved.Phasiligence Consulting Pty Ltd is a registered business entity in Australia.

Phasiligence Consulting Pty Ltd
ABN: 50 699 403 444
ACN: 699 403 444
Melbourne, Victoria, Australia