Regulatory Compliance Initiatives, Inc.

 

 

 

 

Leading the Way

 

Our Services

* Audits/Preparation for Pre-Approval Inspections

Electronic Submissions - INDs, NDAs, ANDAs, and DMFs

Common Technical Document (CTD) including eCTD

Warning letters, Consent Decrees and CAPA Initiatives

All aspects of Quality Assurance/Quality Control including instituting Quality Systems and Quality Policies.

GMP, GCP, and GLP Training

DEA Systems including SOPs, Facility Design, and Compliance audits

ICH Initiatives including Stability Guidance, Impurities, Degradants and Organic Volatile Impurities

Analytical Method Development and Validation, Including Establishing an Analytical/QC Function

Validity Assessments and Data Integrity Audits

Due Diligence Audits

 

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© 2006 Regulatory Compliance Initiatives, Inc.