Regulatory Compliance

CSCS Corp.’s regulatory and quality assurance expertise is one of the best in the industry.  The following is a short list of our capabilities:

• Facilitate plant GMP requirements, including instrument, operation and performance qualifications protocols, validation protocals, API's, CMC sections and 505 (B) - (2)
• Quality audits, including CRO and CMO global suppliers and PAI pre-approval inspections
• Develop and implement compliant systems to meet FDA CFR 210 and 211 and ICH Q7A requirements
• FDA and DEA inspections and compliance
• Auditors with over 25 years of experience
• Pre-Approval Inspections → Preparation for FDA inspections
• REACH and TSCA compliance
• Annual Product Reports (APRs)
• Creation, update and maintenance of Drug Master Files (DMFs)
• Process and Out-of-Specification (OOS) investigations
• Internal auditing program
• Supplier auditing program (domestic and international)
• Purified water system validation
• Equipment qualification & validation
• Process qualification & validation
• Technology transfer
• Compliant equipment cleaning and validation program