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 clinical trial 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 Committees
  • Consultation for federally funded clinical studies, including OHRP Assurance
  • Protocol development in concept, design, preparation, and review
  • Project management
    • Regulatory document collection, review, and maintenance throughout the study lifecycle
    • Informed Consent design/review
    • Clinical trial report review and preparation, including final reports

Meticulous regulatory documentation

  • 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
  • Collect, track, manage, and maintain ongoing documentation throughout the duration of the clinical trial
Regulatory documents for any application

  • Investigational New Drug Applications (INDs) (includes 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

Rigorous close-out process

  • 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 and successful regulatory submissions

  • CCSA has prepared, submitted, and maintained more than 90 INDs/NDAs, CTAs, and IDEs
  • Knowledgeable assistance in responding to regulatory agency inquiries in a timely and effective fashion
  • Scientists and consultants triage clinical protocols, streamlining the regulatory acceptance process to advance the timeline of study initiation
  • CCSA has generated or provided editorial review of Investigator’s Brochures on a variety of drugs and drug candidates

Our portfolio of regulatory-derived products

  • Regulatory strategic planning, FDA (CDRH, CBER, CDER)
  • Communication/correspondence, and meeting organization and execution
  • Preparation and maintenance of more than 90 INDs/NDAs, CTAs and IDEs. Examples:
    1. The first Master IND for an adaptive-based clinical trial design with multiple investigational drugs and biologics
    2. Successful request for an orphan drug designation for a private client
    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 and clinical sections of INDs/NDAs for private clients
    6. Multiple nonclinical toxicology sections in INDs/NDAs in eCTD format sponsored by private clients
  • Preparation of Investigator’s Brochures and Clinical Development Plans in support of government and private-client R&D programs
  • Drafting and maintenance 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.