COMPLIANCE SERVICES

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

CONTACT US FOR EDRL SUPPORT