Pharmaceutical Remediation & Regulatory Affairs
Cell and Gene Therapy
We bring specialized expertise in cell and gene therapy to support safe, cost-efficient, and consistent production. Our team focuses on:
- Quality control testing for stability and reliability
- Streamlined manufacturing processes that lower costs and reduce risks
- Logistics and material management that improve efficiency
Our subject matter experts have deep knowledge
in advanced therapies, helping clients deliver
innovative treatments with confidence.
Regulatory Affairs
Our Regulatory Affairs team helps clients meet FDA and global health authority requirements with confidence. With 25+ years of experience, we provide strategic guidance and hands-on support to keep operations compliant and inspection-ready.
Core Services
- Documentation & Submissions: Documentation review, procedure development, global eCTD publishing, IND/BLA/NDA/ANDA applications, worldwide product registration
- Compliance & Inspection Support: GxP assessments, staff capability evaluations, site audits, inspection readiness, regulatory meeting preparation
- Operational Expertise: Preclinical, clinical, and CMC consulting; manufacturing, lab, and logistics support; investigation closeouts and OOS reduction
By blending regulatory expertise with practical
industry insight, we help clients reduce risk, accelerate approvals, and maintain the integrity of their operations.
Consent Decree Remediation
We provide end-to-end remediation services to help pharmaceutical companies resolve consent decree challenges. Our services include:
- Developing and executing corrective action plans
- Closing compliance gaps and strengthening quality systems
- Supporting clients through FDA interactions
The goal: restore compliance, reduce
future risks, and protect your operations.
Warning Letter Remediation
We guide companies through FDA Warning Letter resolution by:
- Addressing cited deficiencies with corrective and preventive actions
- Enhancing quality management systems to sustain compliance
- Ensuring full alignment with FDA expectations
Our expertise helps safeguard both
compliance and market reputation.
Inspection Readiness
We prepare clients for successful regulatory inspections by:
- Conducting mock audits and gap assessments
- Training staff for inspection preparedness
- Reinforcing quality systems to meet FDA standards
Our readiness programs ensure confidence
during inspections and minimize costly delays.
GXP Training
We deliver custom GxP training programs covering
GMP, GLP, and GCP. Our approach emphasizes:
- Practical, real-world applications
- Interactive learning for lasting retention
- Building a culture of compliance and quality
Well-trained teams are essential to maintaining
product integrity and regulatory compliance.
