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
Risk-Based Validation Services
- Validation Master Plans
- Risk Based Validation
- Equipment/Manufacturing Changes & Qualification
- Manufacturing Process Validation (PV)
- Packaging Process Validation (Pkg V)
- Cleaning Validation (CV) & Calculation of PDE's
- Analytical Methods Validation (AMV)
- Software Validation & Computer Software Validation (CSV) – 21 CFR Part 11
- Capital Projects Management
- Shipping Validation
- Commissioning and Qualification
- Design (DQ), Maintenance Systems & Facilities Qualification
- Validation Protocols, Validation Reports
- Sterility Validation
- Process Validation
Quality Risk Management
- Preliminary Hazard Analysis (PHA)
- Product and Process Risk Assessment
- Critical Process Parameters (CPP) Assessment
- Critical Quality Attributes (CQA) Assessment
- Quality Risk Management (QRM) Tools Implementation
- Sustainability Strategy Development
- QRM Integration to Quality Systems
- Interpretation and Application of QRM Guidelines
- Risk Analysis & Assessment
- Risk ID & Control (FMEA, FMECA, FTA, HAZOP, HACCP)
- ICH Guidelines Compliance – Q8, Q9, Q10
- Development of Risk-Based Supplier Quality Programs and Execution
- Cross-Contamination Risk Analysis
Projects – Scale & Scope
Continuous Improvement
- Process Excellence
- 6-Sigma Methodology
Technology Transfer
- Technology Transfer Strategy Plans
- Quality by Design
- NPI/New Technology Introduction
- Manufacturing Process Gap Analysis
- Site, Component, Packaging, Batch Size Changes
- Process Research, Development, Characterization & DOE
- SUPAC Management
On-Time Workforce Enhancement
Flawless Project Execution
- Project Management
- Project Controls
- Organizational Improvement
- Strategic Planning and Execution
Technical Resources as Needed
- Contract to Hire Services
- Placement Services
- Project Based Consulting
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
Educational Programs
PharmaBioServ offers educational programs that provide technical courses within a team setting environment. Our training is directed towards the Pharmaceuticals, Medical Devices, Biotechnology, and Food Industries located worldwide. Our main objective is to enhance the understanding of theoretical and practical elements in these industries by providing the latest key skills from experienced subject matter experts.
Technical Training and Workshops
- Human Factors and Error Prevention
- Root Cause Analysis and Investigations
- Readiness and Preparation for Agency Inspections
- Effective CAPAs Development and Implementation
- Technical Writing in the Regulated Industry
- Validation Academy (CSV, Process, Facilities, Equipment) for: Medical Devices, Pharma and Bio-Pharma, HTC/P
Regulations Training
- cGMPs for FDA, EMA, and ANVISA Regulations, among others
- GHTF Regulations
- ISO and WHO Guidelines and Regulations
- Regulatory Affairs Procedures
- PDA and ISPE Guidelines