REGULATORY AFFAIRS

Expert attention to your project

We provide a collaborative approach. Our team of toxicologists, chemists, pharmacologists, and certified regulatory affairs professionals work closely to move your project from conception to approval.

Knowledgeable regulatory management

We currently manage INDs for more than 50 government and private-client clinical trials. A number of the studies we manage are considered registration studies by our pharmaceutical partners.

Wide-ranging development expertise

As well as regulatory experience in drug and biologic products for cancer chemoprevention and treatment, our specific capabilities include botanicals and dermatologic, neurologic, hormonal, gastrointestinal, hematologic, urologic, companion diagnostics, and imaging studies.

Regulatory guidance in one place

  • Regulatory intelligence
    • Strategy consultation
  • Representation with regulatory authorities
    • Meeting management
  • Scientific writing to support regulatory submissions
  • Expert review of Chemistry, Manufacturing, and Controls (CMC), nonclinical, clinical, and safety data
  • Special expertise in botanical drug development issues
  • Preparation of SOPs
  • Charter review and administration for Data Safety Monitoring Boards
  • Consultation for federally funded clinical studies, including OHRP Assurance
  • Protocol and Informed Consent development in concept, design, preparation, and review
  • Project management

Regulatory documents for any application

  • Investigational New Drug Applications (INDs) (includes pre-IND meeting packages) provided in electronic Common Technical Document [eCTD] format
  • New Drug Applications (NDAs) (includes eCTD format)
  • Abbreviated New Drug Applications (ANDAs)
  • Investigational Device Exemptions (IDEs)
  • Drug Master Files (DMFs)
  • Clinical Trial Applications (CTAs)
  • Orphan Drug Designations
  • Publications
  • Literature Reviews

Essential regulatory documents for clinical studies

  • Wide-ranging experience managing and maintaining all regulatory documentation on behalf of sponsors during the complete study lifecycle
  • Work closely with study staff at clinical sites to collect all study start-up regulatory documentation in accordance with ICH-GCP guidelines and sponsor specifications while adhering to strict timelines and budgets
  • All study close-out documents collected at study completion in accordance with ICH-GCP guidelines and sponsor requirements
  • All regulatory documentation undergoes rigorous review by our Quality Assurance department
  • All regulatory documentation is managed and maintained via electronic databases and web-based management systems
  • All study close-out documents collected at study completion in accordance with ICH-GCP guidelines and sponsor requirements
  • All regulatory documentation undergoes rigorous review by our Quality Assurance department
  • All regulatory documentation is managed and maintained via electronic databases and web-based management systems

Complete successful regulatory submissions

  • CCSA has prepared, submitted, and maintained more than 100 INDs/NDAs, CTAs, and IDEs
  • Knowledgeable assistance in responding to regulatory agency inquiries in a timely and effective fashion to expedite study initiation
  • CCSA has generated or provided scientific and editorial review of Investigator’s Brochures on a variety of drugs and drug candidates

Our portfolio of regulatory products

  • Regulatory strategic planning, FDA interactions (CBER, CDER, CDRH)
  • Communication/correspondence, and meeting organization and execution
  • Preparation and maintenance of more than 100 INDs/NDAs, CTAs, and IDEs. Examples:
    1. The first Master Protocol IND for an adaptive-based clinical trial design with multiple investigational drugs and biologics
    2. Successful requests for orphan drug designations for private clients
    3. Support in preparing and submitting multiple imaging devices/in vitro diagnostic IDEs
    4. INDs/NDAs for PET imaging agents as well as structured product labels (SPLs) for government-sponsored studies
    5. Nonclinical, CMC, and clinical sections of INDs/NDAs for government and private clients
    6. Submission of SEND datasets for applicable nonclinical toxicology studies
  • Preparation of Investigator’s Brochures and Clinical Development Plans in support of government and private-client R&D programs
  • Drafting and maintenance of imaging charters for government-sponsored studies
  • Design and development of protocols and informed consent documents in support of investigational studies conducted under INDs and IDEs. Examples include, natural products, small molecules, biologics, various imaging modalities (e.g., FDG/PET, MRI, ultrasound), probes (e.g., FES, FMISO, FLT), and agents (e.g., NaF)
  • Preparation of study and progress reports for Regulatory (US and ex-US), DSMB, IRB, and Steering and Executive committees for sponsored studies
  • Preparation of overviews on state-of-the-art biomarker development, including regulatory strategy (e.g., novel imaging probes, predictive biomarkers)
  • Organization and participation in training sessions and workshops for project teams and study staff of government and private client-sponsored investigational studies supporting R&D programs

FDA liaison

 

Our long history of interaction with various government agencies gives us an understanding of what is required for successful filing with the FDA as well as what is required during an FDA audit.

Our proactive approach involves strict monitoring and adherence to timelines to produce well-prepared, cost-effective dossiers of the highest quality and integrity. Our regulatory staff is ready to serve as liaison with FDA.