inspection readiness
Ensure Regulatory Success: Expert Inspection Readiness Services for Pharma Companies
Navigating the complexities of regulatory inspections can be challenging. With ADRES, gain confidence knowing you're fully prepared for FDA, EMA, or other global authority audits. Our comprehensive approach ensures compliance, minimizes risks, and accelerates your product's path to approval."
Preparing for Inspection
After passing phase 2 clinical trials, companies need to prepare for phase 3 clinical trials, submission of a BLA/NDA/MAA and ultimately an FDA/EMA regulatory inspection.
ADRES is experienced in the inspection process and can ensure that your company is prepared.
ADRES is experienced in the inspection process and can ensure that your company is prepared.
Inspectors need to see every document concerning product development, and verify that all data within the submission file has gone through the process of source data verification. In addition, the inspectors will verify that all suppliers, CMOs, clinical sites, service providers, and analytical labs are in full compliance.
ADRES will get you ready for this critical milestone in the development of your product.
ADRES will get you ready for this critical milestone in the development of your product.
| Inspection Readiness | Early Stage | Pre-clinical | Clinical | Registration | Market |
|---|---|---|---|---|---|
| Inspection Readiness process in preparation for regulatory submission |  | |
Inspection Readiness: Ensuring Compliance & Operational Excellence
At ADRES, we specialize in guiding biopharmaceutical and medical device companies through the complexities of regulatory inspections at all clinical stages, from early-phase trials to pre-market submissions. Our proactive strategies ensure your organization is always prepared, minimizing risks and maintaining operational excellence.
Why Inspection Readiness Matters
Regulatory bodies such as the FDA and EMA, or competent authorities, conduct routine and for-cause inspections to verify compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP). Failure to prepare adequately can result in Form 483 observations, clinical holds, warning letters, or delays in key submissions such as Investigational New Drug (IND) applications, New Drug Applications (NDA), Biologics License Applications (BLA), Marketing Authorization Application (MAA), Premarket Approvals (PMA), 510(k), and Technical File (TF) submissions.
Our Inspection Readiness Services
We offer a comprehensive suite of services tailored to your needs at every stage of the regulatory process:
1. Mock Audits & Gap Assessments
- Simulate Inspections: Conduct mock inspections to prepare for FDA, EMA, and other regulatory pre-approval inspections.
- Identify Compliance Gaps: Perform gap assessments to pinpoint areas needing improvement before key submissions.
- Risk Mitigation: Develop corrective and preventive action (CAPA) plans to address identified issues.
2. Documentation & SOP Optimization
- Quality Management Systems: Establish and enhance quality management systems required for early-phase clinical trials through commercialization.
- Regulatory Submission Readiness: Review and refine critical documents such as clinical study protocols, investigator brochures, informed consent forms, and IND/NDA/BLA MAA/PMA/510(k)/TF submissions.
- eTMF Management: Perform periodic reviews of Trial Master Files (TMF/eTMF) to ensure completeness and compliance with regulatory expectations.
3. Training & Personnel Preparation
- Inspection Training: Conduct training sessions to prepare staff for interactions with regulatory inspectors.
- Subject Matter Expert (SME) Support: Provide real-time coaching for SMEs during inspections to ensure effective communication.
- Continuous Education: Enhance staff awareness of regulatory expectations through ongoing training programs tailored to specific clinical phases and submission requirements.
4. Regulatory Intelligence & Continuous Improvement
- Stay Updated: Monitor regulatory updates and trends to ensure alignment with current guidelines.
- Best Practices Implementation: Provide industry insights to adopt best practices in compliance and quality assurance.
- Culture of Compliance: Foster an organizational culture prioritizing compliance and continuous improvement.
Benefits of Partnering with ADRES
- Minimize Compliance Risks: Avoid costly regulatory actions and ensure a smoother path to market.
- Streamline Operations: Enhance efficiency and quality through optimized processes tailored to clinical and regulatory milestones.
- Boost Staff Confidence: Equip your team to handle regulatory interactions effectively at all clinical stages.
- Demonstrate Proactive Compliance: Show regulators your commitment to maintaining high standards throughout the product lifecycle.
Achieve seamless inspection readiness with ADRES’s expert support. Contact us today to discuss a customized plan that aligns with your regulatory and operational needs.
Satisfied Clients
Adres has worked together with, and on behalf of Xbrane in supporting a Drug Substance manufacturing site to become compliant with FDA regulations and...
Erika Egrelius
XBrane
ADRES has worked with Kinexum to provide both supplemental, solo consultations for our Clients, and as an integrated component of our actively engaged...
COO, Brian Oscherwitz
Kinexum
I am writing to provide a testimonial for the services provided to Nectin Therapeutics by Adres. As a satisfied customer, I appreciate the expertise, ...
VP R&D, Guy Cinamon
Nectin Therapeutics
For over a decade, our company has partnered with ADRES for expert regulatory affairs, QA and CMC guidance. Their comprehensive services have proven i...
Miriam Kidron
Oramed
For the past fifteen years, Opko Biologics has been in collaboration with ADRES, a partnership that has been instrumental in enhancing the company's o...
Laura Moschcovich
Opko Biologics
We engaged ADRES to help us evaluate a clinical program in Israel for a novel biologic. We found them to be efficient and knowledgeable in the areas w...
Jeffrey Eisenberg
Xenetic Biosciences
These guys are a customer oriented, dedicated team that most importantly know how to think out of the box within the regulatory environment.”
Oren Hershkovitz, Ph.D
CEO
ADRES regulatory services provide a kind, professional and efficient solution for its clients
Eyal Breitbart, PhD
Senior Vice President Research & Operations VBL Therapeutics
