Complete Solutions for Efficient & Compliant Operations
Our services are in accordance with the latest FDA, EMA, ANVISA, and other international agency regulations and guidelines. All of our services are founded on a philosophy of excellence through our personalized hands-on experience and our trained resources.
Our Services
Data Integrity
Our Team of experts will assist you with your data integrity needs, from specialized training programs, comprehensive risk evaluations, audits to and in-depth collaborative systems assessments. We are committed to provide strategic advice for resolving regulatory findings in an efficient manner. Working with us gives you access to the specific expertise and resources required to uphold the strictest criteria for data integrity, guaranteeing that the data in your company is compliant with all the regulations relevant to your business.
Compliance & Quality Systems
- Gap Analysis & Due Diligences
- Data Integrity Evaluation and Remediation
- PAI Readiness/Mock-ups
- Third-Party certifiers for 483’s, Warning Letters, Consent Decrees
- Preparation of responses to FDA for 483’s, Warning Letters, and Consent Decrees
- Remediation Activities Associated with FDA 483’s, Warning Letters, Consent Decrees
- Response to Health Authorities Observations and Regulatory Actions
- Complaints Management
- Standard Operating Procedures (SOP) development
- QS Compliance Audits – CAPA, APR’s, Change Control, Investigation/Deviation Management
- Stability Protocols & Programs
- Technical writing support
- Risk-Based Supplier Quality Programs Development and Execution
Regulatory Affairs
- US Agents
- Establishment Registrations
- Listing of Products
- Preparation of Regulatory Meetings and Briefing Packages
- Filings Requirements and Post Approval Supplement (IND, NDA, BLA, ANDA, 505 (b) (2) etc.)
- Preparation of 510k and Pre-Market Approval Packages
- Preparation and submission of New Dietary Ingredients Notifications
- Process Change Filings and Reports (AR, CBE, PAS)
- Regulatory Dossiers Due Diligence
Commissioning, Qualification and Validation
- Concept Design Review for Facilities and Utilities
- Facilities, Utilities, Equipment and Laboratory Instruments Qualification
- Risk Assessment and Control (FMEA, FMECA, FTA, HAZOP, HACCP)
- Environmental Monitoring Program strategy
- NPI/New Technology Introduction
- Technology Transfer Strategies – IQ, OQ, PQ
- Technology Transfer/Process Change Filings
- Manufacturing/Packaging Process Gap Analysis
- Equipment/Manufacturing Changes and Qualification
- Site, Component, Packaging, Batch Size Changes
- Process Research, Development, Characterization & DOE
- Manufacturing and Filling Process Validation
- Packaging Process Validation
- Sterility Validation
- Cleaning Validation
- Shipping Validation
- Thermal Mapping
- Toxicological Assessments
- Software Validation & Computer System Validations (CSV) – 21 CFR Part 11
- Analytical Methods Development and Validation (AMV)
- Capital Projects Management
Training & Workshops
- cGMP for Drugs, Biologics, Medical Devices, Cosmetics, Foods, and HCT/P
- Data Integrity
- Regulatory Affairs Topics - FDA, EMA, and ANVISA Regulations, among others
- GHTF Regulations
- ISO and WHO Guidelines and Regulations
- PDA and ISPE Guidelines
- Readiness and Preparation for Agency Inspection
- Quality Risk Management Workshop
- Validation Requirements for Medical Devices, Pharma, Biotech and HTC/P
- Human Error Factors, Root Cause Analysis and Investigation Workshop
- Effective CAPAs Development and Implementation
- Technical Writing for Regulated Environment
Services Throughout the Product Lifecycle
Pre-Clinical Studies
Development Strategic Guide
- Tech Documentation
- Field Support
- QbD Development
- Project Management
- Regulatory Affairs Strategy Definition
Phase I & Phase II
Development Strategic Guide
- Formulation
- Raw Material Characterization
- Tech Documentation
- Validation
- Consulting
- Regulatory Affairs
- Preparation of 510k, PMA,NDA,ANDA, BLA
- FDA Regulatory meeting preparation
Phase III Launch Readiness
- Due Diligence
- Mock PAI and cGMP Gap Assessments
- Supplier Audits
- Internal Audits
- Regulatory Compliance
- Quality Risk Management
- Regulatory Affairs (AR, CBE, PAS)
- Selection of Suppliers
- Supplier Quality Management
- Commissioning and Qualification
- Computer System Validation
- Cleaning Validation
- Process Validation
- Holding Studies
- Training
- Stability Program Management
- Project Management
Phase IV Post-Approval
- Quality Systems support: Batch Records, SOPs, CCs, PQRs, Complaint Management, Process Improvements
- Training
- Supplier Quality Audits and Management
- Temporary placements
- Post Approval Changes
- Labeling Changes
- Process Validation (Stage 3)
- Shipping Validation
- Distribution Studies
- Supplier Audits
- Internal Audits
Rationalization & Decommissioning
- Regulatory notifications
- Outplacement
- Patent Expiration management/Scale Down
- Due Diligence
- Audits