- Quality and Scientific Regulatory Services for Global Bio-/Pharmaceutical Industry
Master File Submission (API)
Master File Submission (API)
USDMF
- For Pharmacopoeia and internal quality active substance DMF development advice
- Writing in CTD & submission in eCTD to CDER, FDA
- Deficiency response for complete assessment review of DMF
- Maintaining Active status of DMF
- Support in major change update
ASMF & CEP
ASMF (EU-MSs)
- For Pharmacopoeia and non-pharmacopoeia API
- Writing Applicant part (AP) and Restricted Part (RP) of ASMF
- Submission to each MSs
- Query response
- ASMF acceptance
CEP (EDQM)
- For Pharmacopoeia API
- Writing Applicant Part (AP) and Restricted Part (RP)
- EDQM submission
- Query response
- Support for EDQM site inspection
- CEP approval letter
API QP AUDIT
Third Party API QP Audit
Experienced EU QP Auditor
Audit
3 Years
CAPA
Submission to Single EU GP
CAPA Acceptance by EU QP Auditor
QP
Informal Mileage
- One- time audit by an independent auditor for single API
- Conserves company’s resources (i.e. cost of travel and stay for buyer specific auditor, one-time engagement of manufacturing and QA personnel)
- One single QP audit can replace numerous MA holder audits
- Single comprehensive CAPA execution to independent EU QP auditor as against multiple CAPAs to different EU QP auditors
- Reduced major observations during renewal inspections since EU QP audit by ex-agency inspector
Master File Submission (API) - Case Study
Read how we imparted in technical review of ASMF