Complete Solutions for Efficient and 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.

Due Diligence Expert Services

Our 30 years working in the Health Care Regulated Industry and innumerable hours of regulatory knowledge by our experts makes Pharma-Bio Serv your preferred partner for your due diligence process!

Download our fact sheet

Services throughout the Product Lifecycle

1.
Research & Development
2.
Pre-Approval
3.
Scale-Up & Transfer
4.
Manufacturing
5.
Post-Marketing

Pre-Clinical Studies

Development Strategic Guide

  • Tech Documentation
  • Field Support
  • QbD Development
  • Project Management
  • Regulatory Affairs Strategy Definition

Phase I & Phase II

  • 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

Our Services

Regulatory Affairs
  • US Agents
  • Establishment Registrations
  • Listing of Products
  • Process Change Filings
  • CAPA, APR Investigations, Change Control, Deviation Management
  • 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.)
  • Preparation and submission of New Dietary Ingredients Notifications
Regulatory Compliance & Quality Systems
  • Remediation Activities associated to FDA 483’s, Warning Letters, Consent Decrees
  • PAI Readiness Audit
  • Mock-up Audits
  • Quality System Compliance Audits
  • Supplier Audit Program Management
  • 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
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

Training

Advanced Knowledge Management

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

Online Training

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

Adding Value To Your Team

HANDS-ON APPROACH

We offer hands-on workshops, and certifications programs addressing the latest industry trends and regulations.

E-LEARNING SERVICES

We have an e-learning platform that provides high-quality education that can be accessed from any location.

HIGHLY EXPERIENCED TEAM

We have highly experienced resources throughout the industry willing to share their knowledge and expertise.

AVAILABLE LANGUAGES

Training can be provided in different languages.

Quality that performs

info@pharmabioserv.com

Regulatory Compliance, Quality & Technology Professional Consulting Services for highly-regulated industries worldwide.

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