Our Services

Comprehensive pharmaceutical quality and compliance solutions tailored to your needs

Pharmaceutical Quality & Compliance

Comprehensive quality management solutions ensuring your operations meet the highest pharmaceutical standards and regulatory requirements.

What We Offer:

Quality Management System (QMS) development and implementation
GMP compliance assessment and gap analysis
Quality Risk Management (QRM) implementation
CAPA (Corrective and Preventive Actions) management
Non-conformance and deviation management
Change control and document management systems
Quality metrics and KPI development
Supplier quality management and vendor qualification
Quality culture development and continuous improvement

Pharmaceutical Quality Audits

Independent, thorough audits to assess compliance, identify risks, and provide actionable recommendations for quality improvement.

What We Offer:

Internal GMP audits across all pharmaceutical operations
External supplier and vendor audits
Pre-approval inspection (PAI) readiness audits
Mock regulatory inspections
Quality system effectiveness audits
Process and procedure compliance audits
Data integrity audits
Audit program development and training
Post-audit CAPA support and follow-up

Pharmaceutical Training & Workshops

Expert-led training programs designed to build GMP knowledge, enhance compliance awareness, and develop quality culture within your organization.

What We Offer:

GMP fundamentals and advanced training
Quality system and documentation training
Regulatory compliance and inspection readiness
CAPA and deviation investigation training
Data integrity and electronic records compliance
Quality risk management (ICH Q9) training
Audit techniques and auditor training
Contamination control and cleanroom practices
Customized role-based training programs
Train-the-trainer programs for sustainable knowledge transfer

Computer System Validation (CSV)

Complete lifecycle validation services for computerized systems in pharmaceutical manufacturing and quality operations.

What We Offer:

CSV strategy and planning
Risk-based validation approach (GAMP 5)
User Requirements Specification (URS) development
Functional and Design Specifications
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Data integrity and 21 CFR Part 11 compliance
System periodic review and revalidation
Cloud system validation
Legacy system validation and remediation

Regulatory Filings & Product Registration

Expert support for regulatory submissions, licensing, and product registration to facilitate market access globally.

What We Offer:

Manufacturing license application and renewal support
Drug Master File (DMF) preparation and submission
Common Technical Document (CTD) compilation
Product dossier preparation (Module 3 - Quality)
Regulatory gap analysis and remediation
Health authority queries and deficiency responses
Product variation and lifecycle management
Market authorization applications (MAA)
Import/export licensing support
Regulatory intelligence and compliance monitoring

IT Services & IT Asset Management

Professional IT infrastructure and asset management services tailored for pharmaceutical and regulated environments.

What We Offer:

IT asset lifecycle management
Hardware and software inventory management
IT infrastructure setup and optimization
Network security and data protection
Backup and disaster recovery planning
IT service management (ITSM) implementation
Help desk and technical support services
IT compliance and audit support
Cloud migration and management
IT budgeting and cost optimization

Need a Custom Solution?

We understand that every organization has unique needs. Contact us to discuss how we can tailor our services to meet your specific requirements.