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
