- Schedule. Mon - Sat 10.00 - 18.00
Greenfield and brownfield facility planning, engineering design, construction oversight.
01
DQ/IQ/OQ/PQ for utilities, cleanrooms, equipment, and computerized systems.
03
Consulting: QMS, ALCOA+ data integrity, sterility assurance, and remediation.
04
Internal audits, mock/pre-agency audits, vendor audits for formulation, API, labs, CROs.
05
Supplier ID, tendering, cost modeling, auditing, and GMP alignment.
06
GMP/GxP training, feasibility studies, cost analysis, and regulatory strategy.
09
Six-system audits, mock audits, vendor qualification, remediation, import alert resolution.
10
ANDA, NDA, BLA, DMF, VMF, IND, 505(b)(2), MAA dossier writing and consulting.
11
Controlled correspondence, ER, DUNS, ESG/CESP portal setup, CARES, PDE/OEL services.
13
PADER, PSUR, CSR, RMP, ICSR processing, and clinical document writing.
14
Controlled correspondence, ER, DUNS, ESG/CESP portal setup, CARES, PDE/OEL services.
16
Greenfield and brownfield facility planning, engineering design, construction oversight.
01
DQ/IQ/OQ/PQ for utilities, cleanrooms, equipment, and computerized systems.
03
Consulting: QMS, ALCOA+ data integrity, sterility assurance, and remediation.
04
Internal audits, mock/pre-agency audits, vendor audits for formulation, API, labs, CROs.
05
Supplier ID, tendering, cost modeling, auditing, and GMP alignment.
06
GMP/GxP training, feasibility studies, cost analysis, and regulatory strategy.
09
Six-system audits, mock audits, vendor qualification, remediation, import alert resolution.
10
ANDA, NDA, BLA, DMF, VMF, IND, 505(b)(2), MAA dossier writing and consulting.
11
Controlled correspondence, ER, DUNS, ESG/CESP portal setup, CARES, PDE/OEL services.
13
PADER, PSUR, CSR, RMP, ICSR processing, and clinical document writing.
14
Controlled correspondence, ER, DUNS, ESG/CESP portal setup, CARES, PDE/OEL services.
16
Our Benefit
Always powering your business for over 30 years
01
Expert Engineers
Skilled experts delivering precise and reliable engineering solutions.
02
Quality Control System
Strong control processes ensuring consistent quality and reliability.
03
Satisfaction Guarantee
A commitment to exceed expectations and deliver complete confidence.
04
International Business
Serving global markets with seamless coordination and execution.
05
Unrivalled Workmanship
Craftsmanship defined by precision, care, and lasting durability.
06
High Professional Staff
Highly trained professionals providing dependable expert support.
Partners
Partners who trust Pharmaden
