B2Pharma Consultancy
Get in touch

End-to-End Pharma Compliance, Audits & Validation

Documentation & SOPs
Regulatory Auditing
Inspection Support
Certification & Validation
Laboratory Supplies
Talk to Expert Audit Support
25+ Years Experience
200+ Clients
Global Compliance
Pharmaceutical Laboratory
100% Audit Success
500+ Validations
FDA COMPLIANCE ✦ EU GMP ✦ WHO STANDARDS ✦ ISO 17025 ✦ SCHEDULE M ✦ FDA COMPLIANCE ✦ EU GMP ✦ WHO STANDARDS ✦

B2Pharma Documentation Services

Audit-ready documentation with regulatory compliance

SOPs

SOPs & STPs

Standard Operating Procedures & Standard Testing Procedures tailored to your operations.

Validation

Validation Documents

Complete validation protocols and reports for equipment, processes, and cleaning.

Audit Ready

Audit-Ready Documentation

Comprehensive document sets prepared for regulatory audits and inspections.

Inspection

Inspection Preparation

Documentation support for regulatory agency inspections and mock inspections.

Data Integrity

Data Integrity (ALCOA++)

Implementation of data integrity principles and documentation for compliance.

Document Let's Start →

Our Comprehensive Services

End-to-end solutions for pharmaceutical compliance and operations

Brands We've Worked With

trusted by pharmaceutical leaders worldwide

Sun Pharma since 2018
Dr. Reddy's partner
Cipla 2020
Lupin 5+ years
Zydus validation
Aurobindo 2022
Biocon audit
Glenmark supply
Torrent 2023
Alkem GDP
Sun Pharma since 2018
Dr. Reddy's partner
Cipla 2020
Lupin 5+ years
Zydus validation
Aurobindo 2022
Biocon audit
Glenmark supply
Torrent 2023
Alkem GDP

Auditing & Inspection Support

B2Pharma's Comprehensive audit preparation and inspection readiness services

1 Internal Audits

Internal Audits

Comprehensive internal audit programs to identify and address compliance gaps.

2 External Audits

External Audits

Support during regulatory and customer audits with documentation and response management.

3 Mock Inspections

Mock Inspections

Simulated regulatory inspections to prepare your team for actual agency visits.

4 Document Handling

Inspection Document Handling

Management of all documentation required during regulatory inspections.

5 Room Readiness

Front/Back Room Readiness

Preparation of both front-room (interview) and back-room (document) areas for inspections.

Our Process Dashboard

94% Readiness
✅ Ready: 12/15
⚠️ In Progress: 2
🔴 Critical: 1
FDA
98% Compliant
WHO-GMP
96% Compliant
ISO 13485
94% Compliant
Pre-audit documentation ✓ Complete
Staff training records ✓ Complete
Equipment qualification ⟳ In Progress
CAPA effectiveness ○ Pending
Prepare for Audit / Inspection →

Certification Audit Services

Get certified with regulatory bodies and international standards

CDSCO Approved

CDSCO / Schedule M

Complete support for CDSCO approvals and Schedule M compliance for manufacturing units.

ISO Standards

ISO Certification Audits

ISO 9001, 13485, 14001, 45001 certification support and audit preparation.

Gap Analysis

Compliance Gap Analysis

Identification of compliance gaps and development of corrective action plans.

Closure Support

Audit Responses & Closure

Preparation of appropriate responses to audit observations and follow-up for closure.

Start Certification Audit

Why Choose Us

Partner with a team that defines excellence in pharmaceutical compliance

10+

Years of

Regulatory Compliance
Excellence

Success Rate 99.8%
500+
Projects Completed
25+
Expert Consultants
40+
Global Markets
0
Compliance Failures
Full Spectrum

Full Spectrum Compliance

End-to-end compliance, audit, and validation services covering every aspect of pharmaceutical operations.

Pharma Pharmaceuticals
Biotech Biotechnology
Medical Devices Medical Devices
Innovative Tools

Innovative Tools

Utilizing cutting-edge technology for accurate, efficient results

Skilled Professionals

Skilled Professionals

Industry veterans with deep regulatory and operational expertise

Regulatory Affairs

Regulatory Affairs Excellence

Successful management of complex compliance challenges across global regulatory landscapes

98% Success
North America
FDA, Health Canada
Europe
EMA, MHRA, EU-GMP
Asia-Pacific
PMDA, TGA, WHO
Middle East
SFDA, GCC Standards
Discover Our Expertise →

Qualification & Validation Services

Comprehensive validation services for equipment, processes, and cleaning

DQ / IQ / OQ / PQ

Design, Installation, Operational, and Performance Qualification protocols and execution.

Equipment Qualification

Qualification of manufacturing, laboratory, and utility equipment as per regulatory requirements.

Process Validation

Process validation for manufacturing processes including API, formulation, and packaging.

Cleaning Validation

Cleaning validation for equipment and facilities to prevent cross-contamination.

Plan Validation Activity

Our Specialized Teams

A Team of Experts. A Standard of Precision.

calibration

Calibration Team

ISO/IEC 17025, GMP · precision & traceability
⚙️ 17025 · GMP
validation

Validation Team

DQ/IQ/OQ/PQ · cleaning · audit‑ready
📋 lifecycle · risk‑based
instrumentation

Instrumentation Team

HPLC/GC/FTIR · qualification & PM
📊 IQ/OQ · data integrity
documentation

Regulatory & Documentation Team

eCTD, SOPs, DMFs · inspection‑ready
📄 former regulators
audit

Audit & Inspection Team

mock audits, CAPA · FDA/WHO‑GMP/MHRA
🔍 ex‑inspectors
meet our team →

Sales & Supply Division

High-quality laboratory supplies with bulk & institutional pricing

Bulk Supply Available
lab chemicals

Lab Chemicals

Analytical grade chemicals, reagents, solvents, and reference standards.

Order Get Quotation
Institutional Pricing
lab glassware

Lab Glassware

Borosilicate glassware, volumetric equipment, and specialized glass apparatus.

Order Get Quotation
Consumables Supply
plasticware consumables

Lab Plasticware

Disposable plasticware, filters, pipettes, and other laboratory consumables.

Order Get Quotation

Our testimonials

Feedbacks from our clients all over world

verified
"
Calibration team helped us pass audit with zero findings. ISO 17025 experts.
Dr. Priya Sharma
Mumbai, India
✅ 5-year ⚡ 50+ instr.
trusted
"
Method validation support made our EU submission smooth and fast.
Michael Chen
Singapore
📋 15+ valid. 🇪🇺 EU ok
premium
"
Supply division delivers high-quality glassware. Bulk pricing excellent.
Dr. Ahmed Khan
Dubai, UAE
🔬 200+ orders ⭐ instit.
verified
"
Audit prep service is top-notch. Mock audits revealed hidden gaps.
Sarah Johnson
London, UK
🔍 FDA ready 📅 annual
trusted
"
Instrumentation team installed HPLC with zero downtime. Great PM.
Carlos Mendez
Mexico City
🧪 HPLC/GC ⚙️ 99% uptime
premium
"
Regulatory team handled three DMF filings. Flawless execution.
Dr. Wei Zhang
Shanghai, China
📄 3 DMFs ⚡ fast-track
verified
"
Calibration team helped us pass audit with zero findings. ISO 17025 experts.
Dr. Priya Sharma
Mumbai, India
✅ 5-year ⚡ 50+ instr.
trusted
"
Method validation support made our EU submission smooth and fast.
Michael Chen
Singapore
📋 15+ valid. 🇪🇺 EU ok
premium
"
Supply division delivers high-quality glassware. Bulk pricing excellent.
Dr. Ahmed Khan
Dubai, UAE
🔬 200+ orders ⭐ instit.
verified
"
Audit prep service is top-notch. Mock audits revealed hidden gaps.
Sarah Johnson
London, UK
🔍 FDA ready 📅 annual
trusted
"
Instrumentation team installed HPLC with zero downtime. Great PM.
Carlos Mendez
Mexico City
🧪 HPLC/GC ⚙️ 99% uptime
premium
"
Regulatory team handled three DMF filings. Flawless execution.
Dr. Wei Zhang
Shanghai, China
📄 3 DMFs ⚡ fast-track
100+ reviews 4.9/5 rating 15+ years

Our Proven Process

A systematic approach to ensure regulatory compliance and successful outcomes

1

Requirement Understanding

Comprehensive analysis of your specific compliance needs and objectives.

2

Gap Analysis

Identification of compliance gaps against regulatory requirements.

3

Planning & Documentation

Development of detailed plans and preparation of all necessary documents.

4

Execution

Implementation of plans with our expert teams and your staff collaboration.

5

Inspection / Certification Support

On-ground support during regulatory inspections and certification audits.

6

Post-Audit Closure

Assistance with response preparation and follow-up until audit closure.

Start the Process

Work With B2Pharma Consultancy

Partner with us for comprehensive pharmaceutical solutions

manufacturing

Manufacturing Units

End-to-end compliance solutions for API, formulation, and packaging units.

Project-based Long-term partnership
startup

Pharma Startups

Compliance foundation setup for new pharmaceutical ventures and startups.

Audit & inspection partner Regulatory guidance
lab

QA/QC Labs

Compliance support for analytical laboratories and quality control units.

Documentation support Instrument qualification
hospital

Hospitals

Pharmacy compliance, sterile area validation, and regulatory support for hospitals.

Compliance audits Validation services
Corporate Enquiry Become a Partner

Let's Talk Compliance

Get a free consultation within 2 hours

256-bit encrypted 2h response NDA ready

Ready for Audit, Inspection or Validation?

Contact our experts now for immediate assistance with your compliance needs

WhatsApp - Documentation WhatsApp - Audit Support WhatsApp - Validation WhatsApp - Supplies
15-min response 100% confidential 24/7 support