CMC drug development plan
ATBio-Consulting builds tailored CMC development plans that give biotech startups a clear and credible path from candidate selection to Phase 1. Each plan defines key activities, costs, and timelines, helping investors assess feasibility and value.
Supported by strong CMC expertise and trusted CRO and CDMO partners, our plans are realistic, phase-appropriate, and aligned with regulatory expectations to support seed and Series A fundraising.
Manufacturability assessment & lead candidates selection
Selecting the right drug candidate requires more than biological activity; it must also be manufacturable, stable, and developable. ATBio-Consulting leads developability and manufacturability assessments through a network of specialized CROs and analytical partners, using a science-driven, risk-based approach to identify technical risks early and guide candidate selection.
Typical activities include :
• Sequence and structure analysis to identify PTM and aggregation risks.
• Expression and purification feasibility studies.
• Formulation and stability screenings under stress conditions.
• Aggregation and solubility assessments.
• Specificity and off-target interaction reviews.
Results are summarized in a comparative developability matrix to support data-driven selection of robust, manufacturable lead candidates.
CRO/CDMO selection
Choosing the right development and manufacturing partners is key to moving a preclinical program into the clinic. ATBio-Consulting supports early-stage biotech companies in identifying and selecting CROs and CDMOs that match their scientific, technical, and strategic needs.
Through an independent and objective process, we help to :
• Define clear project scopes and selection criteria.
• Assess technical capabilities, quality systems, and track records.
• Manage the RFP process by comparing cost, timelines, and risk.
• Support final partner selection and contracting.
This ensures your program is placed with the right partners, reducing risk and keeping development on track.
CMC Project Management
Drug development is a demanding journey that requires tight coordination between science, strategy, and execution. Success depends not only on innovation, but on the ability to align internal teams, CROs, CDMOs, clinicians, and regulators. At ATBio-Consulting, we bring structure and clarity to complex development programs through rigorous project management, clear communication, and proactive riskcontrol, keeping timelines realistic and milestones on track.
Our expertise includes :
• Definition of TPP and QTPP.
• Phase-appropriate assessment of CQAs and CPPs.
• Timelines and budget management.
• Cross-functional coordination.
• CRO/CDMO oversight.
• Risk assessment and mitigation.
• Support for regulatory meetings and Module 3 preparation.
