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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
* Click for more details
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