COMPLIANCE

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The Landscape for Pharma, Biopharma and Biotechnology continues to shift rapidly. With 20+ years of extensive knowledge in the pharma industry, our team stays educated on all regulatory requirements. We take that knowledge and help prospects see where there are gaps and how we can help fill the gaps in order to be compliant with the ever-shifting regulatory FDA standards. 

 REGULATORY & QUALITY SUPPORT 

• Drug and Dietary Supplement Labeling Regulatory Review
• Audits – GMP, Compliance, ISO 9001, Quality Systems, Process, Product, Food Safety, ISO 13485
• Regulatory Filings/Submissions – IND, NDA, ANDA, 510K
• Manufacturing Process Development/Improvement
• Formulation Development/Improvement
• Process Validation
• Method Validation
• Cleaning Validation
• Regulatory Specialists
• GXP Auditing & Gap Assessments
• GXP Regulatory Inspection Support & Training
• QMS, EDMS, ERP Implementation, Support & Training
• Validation and Qualification (IQ, OQ, PQ, UAT, URS, FRS and ROI)
• Medical Device Quality Systems (MDSAP, MDR, or FDA Pre-assessment)
• Software SOP Development
• Supplier/Contract Service Provider Audits (CMO, CRO, CTL, Software, etc.)
• Data Integrity
• Quality Assurance (Batch Record Review, SOP development, etc.)
• Management and Design Controls
• Risk Management
• Manufacturing Compliance Oversight
• Manufacturing Engineering and Support
• Laboratory Controls – Analytical/Quality Control (QC) and CTC Support
• GDP, GLP, GCP and GMP Training

  FDA DRUG & COSMETIC REGISTRATION & LISTING SUPPORT 

• FDA Establishment Registrations
• FDA DRLS and eDRLS
• Drug & Cosmetic Products Re-Certifications
• Labeler Code Requests