Regulatory Affairs
Our regulatory affairs team stands ready to guide you through the complexities of product development, ensuring that every step towards approval is clear, efficient, and expertly managed.
Expert Guidance. Every Step.
Exceptional Service for Every Project
Knowledgeable Regulatory Management
Multidisciplinary Development Expertise
In addition to 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.
Your Path to Regulatory Excellence
Comprehensive Regulatory Solutions for Your Success
Expert attention to your project
We are a boutique full-service CRO offering à la carte and comprehensive services. Our collaborative team of certified regulatory affairs professionals, scientists, and subject matter experts work closely to move your project from conception to successful filing with regulatory agencies.
Wide range of product development expertise
CCSA is a trusted partner in clinical development, offering extensive regulatory affairs support across fields such as oncology & hematology, infectious disease & vaccines, cardiovascular, dermatology, central nervous system, endocrinology, GI & hepatology, cell & gene therapy, ophthalmology, and allergy & respiratory. Our portfolio of investigational products includes small molecules, oligonucleotides, peptides, monoclonal antibodies, mRNA- and DNA-based vaccines, AAV gene therapy, in vitro diagnostics, and drug/device and biologic/device combinations. We are uniquely specialized in early clinical development, prevention, companion diagnostics, efficacy biomarkers, natural products & botanicals, pediatrics, and rare diseases requiring accelerated paths to approval.
Regulatory Strategy and Guidance
- Strategy consultation
- GAP analysis
- Preclinical study strategy
- IND-enabling study guidance
- Expert review of CMC, nonclinical, clinical, and safety data
Regulatory Authority Liaison
- Formal and informal FDA interactions (Type A, B, C, D, and INTERACT meetings)
- Guidance of sponsors by experienced regulatory scientists through the FDA meeting process
- Regulatory strategic planning and FDA interactions (CBER, CDER, and CDRH)
Portfolio of Regulatory Services
- Preparation and maintenance of 5000+ IND, NDA, CTA, IDE, INAD, IMPD, and DMF submissions
- Drafting of nonclinical, CMC, and clinical sections of INDs/NDAs
- Preparation of IBs and CDPs
- Development of clinical protocols and amendments and informed consent documents
- Preparation of clinical study reports
eCTD Publishing and Submission
- eCTD publishing through ESG NextGen
- Pre-IND and other meeting requests
- INDs, NDAs, IDEs, DMFs, CTAs, INADs, etc.
- Expedited approval pathways: Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review
- Orphan Drug Designations
- IND maintenance: annual reports, safety reports, DSURs