Independent Auditing Services

At CRC Oncology, we specialize in delivering comprehensive and tailored services for independent Good Practice (GxP) auditing, with a strong emphasis on preparing your organization for successful FDA inspections. Our dedicated team of experts is committed to ensuring your compliance with regulatory requirements and industry best practices, mitigating risks, and enhancing the quality of your operations.

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Our Services:
Our seasoned auditors conduct thorough and independent assessments of your organization's processes, systems, and documentation. We provide comprehensive independent GxP auditing services in the pharmaceutical sector, including
  • GMP Facility Auditing
  • GLP Laboratory Auditing
  • GCP Clinical Site Auditing
  • GCP Clinical CRO Auditing
  • Other GxP Auditing

Our Focus:
  • Contact us today to discuss how we can enhance your organization's regulatory compliance, prepare you for FDA inspections, and elevate your commitment to quality across the board.
  • Gap Analysis and Remediation: We perform meticulous gap analyses to identify areas of non-compliance, helping you proactively address issues before they become critical. Our experts assist in developing effective remediation strategies and corrective action plans.
  • SOP Review and Development: Our team reviews and develops Standard Operating Procedures (SOPs) to align with current regulatory standards and best practices. Well-structured SOPs are crucial to maintaining compliance and operational efficiency.
  • Documentation and Recordkeeping Review: Our experts meticulously review your documentation and recordkeeping practices to ensure accuracy, completeness, and compliance with regulatory guidelines.
  • Continuous Improvement Strategies: We collaborate with your team to implement continuous improvement strategies, enhancing your quality management systems and ensuring sustained compliance over time.

Contact us today to discuss how we can enhance your organization's regulatory compliance, prepare you for FDA inspections, and elevate your commitment to quality across the board.

Regulatory Submission Services

At CRC Oncology, we specialize in delivering tailored regulatory submission services focused on the requirements of the U.S. Food and Drug Administration (FDA). With extensive experience navigating the intricacies of FDA regulations, we guide your pharmaceutical product's journey through the U.S. regulatory process, from Investigational New Drug (IND) applications to New Drug Applications (NDA), Biologics License Applications (BLA), and beyond.

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Our Services:
  • IND to NDA/BLA Expertise: Our seasoned regulatory experts provide comprehensive support for your product's regulatory progression, from IND to NDA/BLA submissions, ensuring compliance and strategic success. We have successfully guided numerous clients through FDA submissions and interactions, leading to successful outcomes.
  • FDA Regulatory Submissions: We specialize in preparing and submitting a range of regulatory documents to the FDA, including INDs, NDAs, BLAs, pre-IND meeting packages, and more. Our team ensures accurate compilation and timely submission.
  • FDA Meeting Preparation and Representation: We excel in preparing your team for FDA meetings, including Pre-IND meetings, Type A/B/C meetings, Advisory Committee Meetings, and more. Our experts provide strategic guidance, document preparation, and representation during interactions with the FDA.
  • Submission Strategy and Planning for FDA: Our regulatory strategists collaborate with you to develop a submission strategy tailored to FDA requirements, whether for NDA or BLA. We guide you through planning, ensuring a well-prepared pathway to FDA approval.
  • FDA Document Authoring and Review: Our skilled writers produce high-quality regulatory documents specific to FDA submissions, ensuring accuracy and compliance. Rigorous review processes maintain the highest standards.
  • FDA Regulatory Project Management: We manage the entire FDA submission process, from strategy development to final submission. Our project management ensures timelines are met, and submissions are of exceptional quality.

Contact us today to discuss how our expertise can help you achieve successful submissions, secure FDA approvals, and bring your pharmaceutical products to the market efficiently and compliantly.

Advisory Consulting

Advisory Consulting At CRC Oncology, we specialize in delivering comprehensive and strategic regulatory and clinical development consultant services tailored to pharmaceutical companies operating in the United States. With deep industry expertise and a results-driven approach, we guide your product's journey through the entire spectrum of development, from Investigational New Drug (IND) applications to New Drug Applications (NDA) and Biologics License Applications (BLA), ensuring regulatory success and clinical excellence. Our services encompass regulatory strategies, clinical and nonclinical designs, CMC planning, expedited approval pathways, labelling planning, and more, ensuring your success in the dynamic pharmaceutical landscape.

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Our Services:
  • Regulatory Strategy and Planning: Our experienced consultants work closely with you to develop a robust regulatory strategy that aligns with FDA requirements. We tailor strategies for each phase of development, leveraging expedited approval pathways such as Fast Track Designation, Regenerative Medicine Advanced Therapy (RMAT) designation, and Orphan Drug Designation.
  • Clinical Development Planning: Our experts design tailored clinical development plans that optimize study design, endpoints, patient populations, and trial phases. We ensure your trials are aligned with regulatory expectations and market needs.
  • Clinical Trial Design and Execution: We provide guidance in designing and executing robust clinical trials that generate high-quality data. Our consultants collaborate with your team to ensure trials are conducted efficiently and ethically.
  • CMC (Chemistry, Manufacturing, and Controls) Strategy: We offer specialized CMC consulting, ensuring your product's manufacturing processes, quality controls, and specifications meet regulatory requirements and align with your development goals.
  • Nonclinical Study Design: Our experts provide guidance in designing nonclinical studies that support safety and efficacy claims. We ensure nonclinical data is aligned with your regulatory submissions.
  • Data Analysis and Reporting: Our consultants offer expertise in data analysis, interpretation, and reporting for regulatory submissions. We ensure your data effectively supports your product's safety and efficacy.
  • Labelling Planning for Marketing Applications: Our consultants assist in developing strategic labelling plans for marketing applications. We ensure your product's labelling aligns with regulatory requirements and effectively communicates essential information to healthcare professionals and patients.

Contact us today to discuss how our expert consultant services can help you achieve successful submissions, secure approvals, and bring your pharmaceutical products to market.