CCS provides specialized solutions that combine science, technology, and business to achieve well-crafted, risk-based compliance strategies. We provide comprehensive consulting services to both large and small corporations and businesses that produce or manufacture drugs, medical devices, foods, biological products, and veterinary feed and pharmaceuticals. We provide global and start-up companies with comprehensive assistance and insight in preparing for FDA inspections, obtaining premarket approval, staying in compliance with FDA regulations and resolving regulatory issues and concerns.

CCS offers insight that only FDA veterans can provide on all products regulated by FDA. Our affordable consulting services include:
  • cGMP Compliance ∇
    • Quality
    • Quality by Design
    • Quality Risk Management
    • Corrective and Preventive Actions
    • Change Control
    • Quality Unit
    • System Inspection Model
    • Quality Systems Model
  • Quality Systems Compliance ∇
    • Quality Assurance & Quality Control
    • Design Control
    • Process Validation
    • Buildings & Environment
    • Master Records
    • Document Control & Change
    • Labeling/packaging/storage/distribution
    • Complaints
  • Import and Export Compliance ∇
    • FDA detentions/refusals
    • Civil Seizure Actions
    • Export Certificates
    • Establishment Registration
  • Corrective Action Plans ∇
    • Remedial corrections
    • Root Cause Analysis
    • Preventive Action
  • Standard Operation Procedures ∇
    • Development of performance characteristics, testing methodology, manufacturing practices, product standards, scientific protocols, compliance criteria, ingredient specifications, labeling, or other technical or policy criteria
  • Product Labeling ∇
    • Biologics, Cosmetics, Dietary Supplements, Drugs (human and veterinary), Foods and Medical devices
    • Limitations Statement
    • Product Names and Date of Initial U. S. Approval
    • Boxed Warning
    • Recent Major Changes
    • Indications and Usage
    • Dosage /Administration/Forms Strengths
    • Contraindications
    • Warnings and Precautions
    • Adverse Reactions
    • Drug Interactions
    • Use in Specific Populations
    • Patient Counseling Information Statement
  • Product Advertisement and Promotion ∇
    • Product Claim Advertisements
    • Reminder Advertisements
    • Help-Seeking Advertisements
    • Other Product Claim Promotional Materials
    • Risk Disclosure Requirements
  • Regulatory Submissions ∇
    • INDs
    • NDAs
    • ANDAs
    • DMFs
    • CMC
    • 510 (k) s
    • IDEs
    • PMAs
    • FAPs
    • BLAs
    • INAD
    • NADA
  • GxP Audits/Inspections ∇
    • Good Clinical Practices (GLPs)
    • Good Laboratory Practices (GLPs)
    • Good Manufacturing Practices (GMPs)
  • Regulatory Correspondence and Responses ∇
    • FDA 483 Responses
    • Warning Letters
    • Untitled Letters
    • Consent Decrees
  • Product Registration and Listing ∇
    • Biologics
    • Devices
    • Drugs (Human and Veterinary)
    • Food
    • Tobacco
  • Food Facility Registration ∇
    • Collection of registration information required by the Bioterrorism Act
    • Registration of each facility engaged in the manufacture, processing, packaging or holding of food for human/animal consumption in the U.S.
    • Updates to registration as needed
    • Annual reviews
    • Obtaining registration number from FDA
  • Expert Witness/Testimony ∇
    • Adjudicating insurance claims
    • Experts in depositions
    • Civil litigation
  • Bioresearch Monitoring ∇
    • Clinical Trials
    • Sponsor Monitoring
    • Institutional Review Boards
    • Human Subject Protection
  • Product Recalls ∇
    • Drugs (human and animal)
    • Medical devices
    • Radiation-emitting products
    • Vaccines
    • Blood and blood products
    • Transplantable human tissue
    • Animal feed
    • Cosmetics
    • Foods (approximately 80 percent of the foods eaten in the United States)
  • Validation ∇
    • Process
    • Software
    • Equipment
  • Seminars and Training ∇
    • Critical Path
    • Quality Systems
    • Current Good Manufacturing Practices (cGMPs)
    • Risk Management
    • Product Recalls
    • Imports/Exports
    • Food Compliance
    • Dietary Supplement
    • Cosmetic Compliance
    • FDA Regulatory Compliance & Enforcement
  • U.S. Agent Services ∇
    • Assisting FDA in communications with the foreign establishment,
    • Responding to questions concerning the foreign establishment's devices that are
    • imported or offered for import into the United States,
    • Assisting FDA in scheduling inspections of the foreign establishment and
    • Serving as liaison to receive information or documents, and such an action shall be
    • considered to be equivalent to providing the same information or documents to the foreign establishment.
  • FDAAA,Title VIII ∇
    • Certification to accompany drug, biological product and medical device submissions
  • Freedom of Information (FOI) and Information Services ∇
    • Making FOIA request
    • FOIA Fees
    • FOIA regulations and Appeals
Seminars and Training

CCS offers a variety of seminars designed to help the regulated industry comply with today’s complex laws and regulations. They are conducted by instructors with science-based backgrounds coupled with in-depth knowledge of FDA’s requirements and expectations. Some of the experts teaching the courses authored FDA policy and guidance documents, developed and evaluated compliance programs or designed and implemented complex regulatory enforcement strategies during their tenure at FDA. This is a cost-effective way to learn from veterans with an insider’s perspective on FDA policies and procedures. We will conduct in-house training programs tailored to your specific needs to help satisfy your training needs.

If you don't see the specific service category that you're looking for from our extensive offerings, please feel free to either e-mail or call us to communicate directly with one of our professional associates who will be happy to assist you.

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