Services

Efficient & Compliant Operations

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.

Complete Solutions

Services

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

Project Management Services

• Capital Projects Management
• Project Tracking, Resource Loading, Cost Control
• Project Management Office
• Gantt Chart
• Control of Activities

Validation

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

Regulatory Compliance

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

Quality Risk Management

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

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

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

“A true leader is that one who sees the future potential rather than the current being, then leads and develops to create the one that will lead what you lead today.” Elizabeth Plaza, Founder & President, PharmaBioServ
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.

Key Benefits

Adding Value To Your Team

1
Hands-On Approach

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

2
E-Learning Services

We have an e-learning platform that provides high-quality . We support all of our customers in meeting their needs.Wsupport all of our customers in meeting theirneeds.

3
Highly Experienced team

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

4
Available Languages

Training can be provided in different languages.

Online Training

e-Learning

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

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 Guidances and Regulations

  • Regulatory Affairs Procedures

  • PDA and ISPE Guidelines

General Skills for Industries

  • MS Project & Excel (Basic, Intermediate, Advanced) 

  • Statistics for the Regulated Industry

  • Project Management

Corporate and Team Development / Coaching

  • Emotional Intelligence 

  • Organizational Coaching

  • Managing Change in the Industry 

  • Leadership Skills Development Training 

  • Customer Satisfaction

  • Effective Negotiation Techniques

  • Conflict Management

  • Open and Assertive Communication