Audits for API, Excipients, Intermediates, KSM, Chemicals & Packaging manufacturing sites and finished product facilities
Site readiness assessments for USFDA, EMA, WHO, MHRA, and other global inspections
Gap analysis with detailed remediation roadmaps
Full support during regulatory inspections to ensure smooth outcomes
Solutions for Warning Letters, FDA 483s, and critical audit observations
Consulting for Greenfield projects including plant setup & QMS design
SOP simplification for better adoption and reduced errors
Customized training programs for teams at all levels
Strategic guidance for new product development and submissions
Registration strategies for regulated & emerging markets
Detailed documentation review for process and product compliance
Product filing and variation management
CMC data generation support for successful approvals
Gap analysis & remediation for documentation deficiencies
Support in obtaining DUNS Number and FEI Number
QSAR-based Genotoxic impurity evaluation
Nitrosamine impurity assessment and risk mitigation
Ongoing assistance for amendments, queries, and annual reports
Computer System Validation (CSV) for GxP systems
Computerized System Assessment (CSA) for risk-based compliance
Digital solutions ensuring regulatory IT compliance
ALCOA+ based audits to ensure trustworthy records
Data governance remediation plans
Digital compliance strategies for secure data management
Analytical method validation to global pharmacopeia standards
Process validation for efficiency & reproducibility
Technology transfer to ensure seamless scaling
Troubleshooting for complex technical challenges
Risk-based data analytics for informed decision-making
Advanced trend reviews for proactive improvements
Cost efficiency & productivity optimization strategies
We provide end-to-end support for organizations looking to expand, divest, or consolidate their pharmaceutical manufacturing facilities. Our services include: