Our Services are in accordance with the latest FDA, EMA, ANVISA, and other international agency regulations and guidelines. All our services are founded on a philosophy of excellence through our personalized hands-on experience and our trained resources.
We understand our client's requirements and help them to ensure cGMP compliance through fulfilling day-to-day needs. All work performed is properly recorded through high quality documentation.
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Project Management Services
• Capital Projects Management
• Project Tracking, Resource Loading, Cost Control
• Project Management Office
• Gantt Chart
• Control of Activities
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 Systems Support
• Remediation Activities associated to FDA 483’s, Warning Letters, Consent Decrees
• PAI Readiness/Mock-ups
• QS Compliance Audits
• CAPA, APR Investigations, Change Control, Deviation Management
• Complaints Management
• SOP Development / Revisions
• Gap Analysis, Remediation & Implementation Plans
• Development and Execution of GMP Training Programs
• Supplier Quality Management
• Stability Protocols & Programs
• Change Management & Control
Regulatory Affairs
• US Agents
• Establishment Registrations
• Listing of Products
• Preparation of CTD (all 5 modules)
• Regulatory Dossiers Compliance Assessments
• Preparation of responses to FDA for 483’s,
Warning Letters, and Consent Decrees
• Preparation of 510k and Pre-Market Approval Packages
• Preparation of Regulatory Meetings and Briefing Packages
• Filings Requirements and Post Approval Supplement (APR, AR, CBE, IND, NDA, ANDA, etc.)
• Process Change Filings
• Preparation and submission of New Dietary Ingredients Notifications
With decades of experiences in Quality Risk Management (QRM) projects, we know how to successfully implement QRM Strategies. We improve your quality results through effective Quality Risk Management.
We make possible a sustained validated state of control while maximizing operational efficiency by implementing the latest tools and standards, such as:
• 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
• Process Excellence
• 6-Sigma Methodology
• 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
Outsourcing through PharmaBioServ has demonstrated to be a cost-effective solution that allows our clients to focus on more strategic, revenue-generating core competencies. We are Certified as Minority Controlled Supplier.
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
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.
We offer hands-on workshops, and certifications programs addressing the latest industry trends and regulations.
We have an e-learning platform that provides high-quality education that can be accessed from any location.
We have highly experienced resources throughout the industry willing to share their knowledge and expertise.
Training can be provided in different languages.
Our e-learning platform provides high-quality online training services. Our goal is to support all of our customers in meeting their GMP training needs. Please contact us for more information.
eNTER e-learning tRAINING
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
cGMPs for FDA, EMA, and ANVISA Regulations, among others
GHTF Regulations
ISO and WHO Guidances and Regulations
Regulatory Affairs Procedures
PDA and ISPE Guidelines
MS Project & Excel (Basic, Intermediate, Advanced)
Statistics for the Regulated Industry
Project Management
Emotional Intelligence
Organizational Coaching
Managing Change in the Industry
Leadership Skills Development Training
Customer Satisfaction
Effective Negotiation Techniques
Conflict Management
Open and Assertive Communication
Regulatory Compliance, Quality & Technology Professional Consulting Services for highly-regulated industries worldwide.
