Services
We help pharmaceutical and biotechnology companies improve operational performance, stay fully compliant with regulations, and achieve lasting excellence through practical, results-oriented auditing and consulting services. Our approach is built to address the specific challenges of a highly regulated and fast-paced industry.
Our experienced auditors bring strong industry knowledge and a proven ability to deliver customized, effective solutions. We work closely with each client to identify key insights, simplify processes, and support long-term strategic goals in an ever-changing pharmaceutical environment.
GxP
Auditing
Providing comprehensive audit solutions to help organizations ensure the quality, safety, and compliance of their pharmacovigilance and clinical operations. Our expert team delivers strategic and operational support through a wide range of services, including:
GVP
- Full PV system audits
- PV process audit
- Partner audits
- Vendors audits (including Patient Support Services (PSP); Market Research Programs (MRP); Digital Initiatives; Promotion Activities; Call Centers; PV providers)
- Distributors audits
- Inspection preparation
GCP
- Vendor audits
- Laboratory audits
- Internal audits
- Investigator Site audits
- Inspection preparation
GDP/GMP
- Qualification audits
- Requalification audits
- For caused audits
- Inspection preparation
Converting Knowledge into Results
Consulting
We support organizations in strengthening their quality systems and ensuring ongoing regulatory compliance. Our services cover the design, implementation, and continuous improvement of robust quality frameworks tailored to the needs of GxP operations
Our expert team provides strategic and operational support in key areas, including:
Quality Management Systems (QMS) development.
On-site Expert Support
Standard Operating Procedure (SOP) writing and review.
GVP gap analysis.
Compliance and Key Performance Indicators (KPIs).
Post audit/inspection Corrective and Preventive Action (CAPA) formulation and response.
Pharmacovigilance training.
Pharmacovigilance System Master File (PSMF).
Safety Data Exchange Agreements (SDEA).
Why Hire dAudit?
- 20+ Years of Experience
- Trusted Consultancy
- Qualified Specialist