ADRESAUDITS · CMC & MANUFACTURING · CLINICAL OPERATIONS
Keep control across your product program.
Independent audits and hands-on oversight for biopharma teams. ADRES connects quality, CMC and manufacturing, and clinical operations—helping you see the risks, challenge the gaps, and follow through with internal teams and external partners.
Campaign offer: free 45-minute introductory call, followed by a complimentary one-hour expert meeting.
THREE CONNECTED SERVICE AREAS
From a focused audit to ongoing oversight.
Qualifying a partner, transferring a process, scaling manufacturing, running a clinical program, or preparing for an inspection? Each stage needs clear responsibilities, dependable records, and timely decisions.
Start with the area that matters most. ADRES can support a defined assignment or provide ongoing expert input across the interfaces between quality, manufacturing, and clinical work. Inspection readiness remains part of the offering—not the only reason to engage.
Audits & readiness
Risk-based internal, supplier and vendor audits, including manufacturing sites, laboratories, CROs and clinical sites. Receive clear findings and a practical CAPA plan, with mock inspections and team preparation when relevant.
Explore audit services →CMC/manufacturing oversight
Support CMO/CDMO selection and supervision, process development, scale-up, technology transfer, analytical methods, and validation planning. Review manufacturing records and connect CMC decisions with the product’s development stage and submission needs.
Explore CMC services →Clinical operations oversight
Strengthen sponsor visibility into CROs, clinical sites and other service providers. Review study documents, TMF/eTMF quality, protocol deviations, and clinical quality risks, with follow-up on actions and escalation of issues.
Explore clinical QA & oversight →WHERE OVERSIGHT ADDS VALUE
Outsourced work. Connected decisions.
A report alone does not close a gap. We help teams connect findings with the people, records and actions needed to move the program forward.
- Partner qualification and clear scope across CMOs/CDMOs, CROs, laboratories and sites
- Manufacturing records, process changes, deviations, CAPA and technical-transfer interfaces
- Clinical documents, trial records, protocol deviations and vendor performance
- Data integrity, evidence traceability and timely issue escalation
- Audit follow-up, inspection preparation and accountable action owners
A SENSIBLE STARTING POINT
Turn the next challenge into a workable plan.
Share your priorities
Tell us your product stage, current partners, upcoming milestones, and where visibility or expert capacity is missing.
Define the assignment
Agree a targeted audit, a CMC/manufacturing workstream, or clinical oversight support—with clear responsibilities and deliverables.
Act and follow through
Translate findings and technical input into priorities, then track the agreed actions with your team and partners.
COMMON QUESTIONS
The support should fit the work.
Do we need an inspection on the calendar?
No. Support can begin with partner qualification, a manufacturing or technology-transfer milestone, clinical program oversight, or recurring quality issues. Audit and inspection preparation are additional applications of the same practical approach.
What is the difference between an audit and oversight?
An audit is a defined assessment with findings. Oversight is continuing review, challenge, coordination and follow-up. You may need either or both; we agree the scope and keep responsibilities clear.
Can we start with just one service area?
Yes. Start with audits, CMC/manufacturing, or clinical operations oversight. Cross-functional support can be added when the program needs it.
Does this replace our CRO, CDMO or internal team?
The engagement is designed to strengthen your team’s visibility and decision-making, not replace ownership within your organization. Specific execution responsibilities are agreed in scope; an audit or readiness review does not guarantee regulatory approval or a finding-free inspection.
CAMPAIGN OFFER
Start with a call. Then pick our brains.
45-minute introductory call + a complimentary one-hour “Pick our brains” meeting with an ADRES expert.
Introduce your company, product stage and current challenge. Then bring your audit, CMC/manufacturing, or clinical operations oversight questions to a one-hour discussion with an expert matched to your topic.
Both meetings are free. Use the form below to request your introductory call and expert session.
Request the campaign offer by email →Explore our audit, CMC and clinical QA services, or inspection readiness.
Request your introductory call and expert session
FROM THE ADRES KNOWLEDGE HUB
Practical reading across the program.
Phase-appropriate GMP
A practical webinar discussion of quality systems, outsourced manufacturing oversight, documentation and the evolution of controls during development.
Read and watch the GMP discussion ↗Build clinical quality from the start
Practical perspectives on sponsor oversight, vendor qualification, quality indicators, TMF health checks and follow-up of clinical audit findings.
Read the clinical QA article ↗Build a data integrity culture
Ideas for leadership, training, issue escalation and everyday behaviors that support reliable records across quality, manufacturing and clinical work.
Read the data integrity article ↗Preparing for an FDA inspection? Explore FDA’s revised PAI program ↗ and responding to FDA Form 483 ↗.
These articles provide background, not a program-specific assessment or a comprehensive guide to current requirements. The Form 483 article discusses FDA’s March 2026 draft guidance with nonbinding recommendations.
Request your introductory call →