Cogence for Pharma & Biotech
Bring Better Therapies to Patients Faster
Cogence orchestrates product development, technology transfer, change control and quality processes as connected, auditable workflows. R&D, CMC, quality, regulatory, manufacturing and your CDMO and supplier partners work from one source of truth.
- Discovery Handoff
- Process Development
- Clinical Supply
- Tech Transfer
- Process Validation
- Commercial Launch
- Lifecycle Management
The challenge
Every day saved in development matters to patients
Moving a molecule from the lab to commercial supply takes dozens of handoffs between functions, sites and partners. All of them happen under GMP and regulatory scrutiny. When tech transfer, change control and quality events run on documents and email, timelines stretch and inspection readiness suffers.
Cogence makes those handoffs structured and traceable, so your teams move faster with the control your quality system requires.
- Gated development programs with clear decisions
- Smooth technology transfer to internal sites and CDMOs
- Change control assessed for quality and regulatory impact
- Supplier and CDMO quality managed in one place
- Deviations and CAPA closed faster, with full records
Development & technology transfer
From process development to commercial manufacturing
Cogence coordinates the cross-functional work that takes a product from development into clinical and commercial supply, in line with ICH Q8, Q9 and Q10 principles.
Program stage gates
Run development programs with defined deliverables, governance reviews and go/no-go decisions at each stage.
Technology transfer
Plan and track tech transfer to internal sites and CDMOs: transfer protocols, gap assessments, documentation and readiness approvals.
Specifications & master data
Manage materials, specifications, bills of materials and master batch records with version control and approvals.
Quality risk management
Run risk assessments and FMEAs on processes and changes, and link controls to critical quality attributes and process parameters.
Validation
Coordinate process, cleaning and equipment validation activities, protocols and reports across functions.
Electronic signatures
Capture approvals with electronic signatures and complete audit trails to support 21 CFR Part 11 and EU Annex 11 practices.
CDMO & supplier collaboration
Work with CDMOs and suppliers as one team
Outsourced manufacturing and critical materials make partners part of your quality system. Cogence gives them a shared, controlled place to work with you.
CDMO collaboration
Share documents, batch status, change requests and investigations with contract manufacturers through partner portals.
Supplier qualification
Qualify suppliers of APIs, excipients and components, manage quality agreements and audits, and track supplier changes.
Readiness for launch
Coordinate materials, packaging, labeling and site readiness across functions and partners for each launch market.
Change control & quality
Closed-loop quality across the product lifecycle
After approval, every change and quality event must be handled consistently and on record. Cogence includes cross-functional process templates for each, plus several types of root cause analysis.
Change control
Assess changes for quality, validation and regulatory filing impact across sites and markets before you implement them.
Deviations & CAPA
Manage deviations, investigations and CAPAs through root cause, correction and effectiveness checks, all the way to closure.
Complaints
Capture, investigate and trend product complaints, and link findings to batches, materials and corrective actions.
Built for partners
Supplier development for manufacturing readiness
Supplier development plays a central role in getting CDMOs and critical suppliers ready for clinical and commercial manufacturing. Cogence structures assessments, readiness plans and improvement actions with every partner.
Cogence Applications
Ready-to-use applications for every step
Cogence includes ready-to-use applications for program management, phase gates, change management, supplier quality and corrective action, so your scientists and quality teams can focus on patients.
Explore the applications