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Engineers reviewing pharmaceutical facility plans on a production floor

Services Pharmaceutical Consulting Services

Comprehensive pharmaceutical expertise under one accountable partner.

Engage us for a single mandate or the entire build — and the regulatory rigor in between.

The full scope

The full scope, end to end.

We have owned, built, licensed, and scaled the operations we now advise on — so our guidance comes from the operating floor, not the sidelines.

Pharmacist and formulation scientist pipetting samples in a development laboratory

01

Formulation Development

Sterile and non-sterile product development backed by rigorous analytical science.

Product Development

Sterile Products

  • Injectable Formulations
  • Peptide Products
  • Hormones
  • Ophthalmics
  • IV Preparations
  • Lyophilized Products

Non-Sterile Products

  • ODT Tablets
  • Troches
  • Capsules
  • Powders
  • Oral Suspensions
  • Creams
  • Gels
  • Lotions
  • Nasal Sprays
  • Sublingual Products
  • Films

Analytical Development

  • Method Development
  • Method Validation
  • Forced Degradation
  • Stability Protocols
  • Impurity Profiles
  • Content Uniformity
  • Dissolution Development
Consultants walking a commercial pharmaceutical production line during scale-up

02

Scale-Up & Commercialization

From pilot batches to commercial output — engineered for yield, reproducibility, and transfer.

Pilot Scale Manufacturing

  • Process Development
  • Equipment Selection
  • Batch Optimization
  • Yield Improvements
  • Manufacturing Transfer

Commercial Scale-Up

  • Technology Transfer
  • Process Validation
  • Scale-Up Studies
  • Process Characterization
  • Equipment Qualification

Manufacturing Support

  • Batch Records
  • SOP Development
  • Process Validation
  • Operator Training
Automated pharmaceutical filling and packaging equipment in a production suite

03

Pharmaceutical Equipment & Tooling

Specifying, sourcing, and qualifying the right equipment for every dosage form.

Equipment Selection

Solid Dose

  • Tablet Presses
  • High Shear Granulators
  • Fluid Bed Dryers
  • Blenders
  • Mills
  • Coating Systems

Sterile

  • Isolators
  • Filling Lines
  • Lyophilizers
  • Depyrogenation Ovens

Compounding

  • Unguators
  • Planetary Mixers
  • Homogenizers
  • ODT Equipment
  • Troche Equipment

Equipment Services

  • URS Development
  • FAT/SAT
  • IQ/OQ/PQ
  • Validation
  • Training
Consultant reviewing pharmaceutical facility blueprints beside a cleanroom suite

04

Facility Design & Engineering

Compliant facility design and engineering, from 503A pharmacies to 503B suites.

503A Pharmacy Design

  • USP 795
  • USP 800
  • Workflow Design
  • HVAC Review
  • Facility Layout

503B Facility Design

  • cGMP Design
  • Sterile Suites
  • Cleanroom Design
  • Environmental Monitoring

Engineering Services

  • Mechanical
  • Electrical
  • Plumbing
  • HVAC
  • Pressure Cascades
Regulatory and compliance documentation review at a pharmaceutical operations desk

05

Regulatory & Compliance

FDA, board of pharmacy, DEA, and quality-systems readiness, end to end.

FDA Consulting

  • 483 Response
  • Warning Letter Response
  • FDA Readiness

Board of Pharmacy

  • New Licensure
  • Change of Ownership
  • Non-Resident Licensing

DEA

  • DEA Registration
  • Security Reviews
  • Controlled Substance Programs

Quality Systems

  • CAPA
  • Change Control
  • Deviations
  • Investigations
  • Complaint Handling
  • Recall Programs
Consultant leading a quality assurance walkthrough in a pharmaceutical facility

06

Quality Assurance & Quality Control

QA and QC programs built to withstand inspection and protect product quality.

QA Systems

  • SOP Development
  • Training Programs
  • Internal Audits
  • Supplier Qualification

QC Programs

  • Potency Program Design
  • Stability Programs
  • Environmental Monitoring Program
  • Water Activity Program
Analytical laboratory team reviewing method development with chromatography instruments

07

Analytical Laboratory Design & Oversight

Analytical laboratory design, implementation, qualification, and strategic oversight.

Laboratory Setup

  • Laboratory Design
  • Instrument Selection
  • Method Implementation
  • Qualification (IQ/OQ/PQ)
  • Strategic Oversight

Capabilities Enabled

  • Potency / Assay
  • Dissolution
  • Content Uniformity
  • Identification
  • Method Validation
Microbiology laboratory team reviewing sterility and environmental monitoring plans

08

Microbiology Laboratory Design & Oversight

Microbiology laboratory design, implementation, qualification, and strategic oversight.

Laboratory Setup

  • Laboratory Design
  • Equipment Selection
  • Method Implementation
  • Qualification (IQ/OQ/PQ)
  • Strategic Oversight

Capabilities Enabled

  • Sterility
  • Endotoxin
  • Bioburden
  • Environmental Monitoring

Cleanroom Support

  • Sampling Program Design
  • Monitoring Strategy
  • Personnel Program Design
Pharmaceutical distribution warehouse aisle with palletized inventory

09

API Wholesale & Repackaging

Vetted API sourcing, repackaging, and resilient supply-chain programs.

API Sourcing

  • FDA Registered Suppliers
  • USP Grade APIs
  • Global Sourcing

Repackaging Services

  • Custom Packaging
  • Labeling
  • Lot Traceability

Supply Chain

  • Vendor Qualification
  • Approved Supplier Programs
Pharmaceutical operations analytics dashboard on a screen in a distribution warehouse

10

Software, AI & Digital Transformation

Empowering modern pharmaceutical operations through ERP, AI, automation, advanced analytics, and connected digital ecosystems that improve operational efficiency, compliance, and decision-making.

Pharmaceutical ERP

  • ERP Strategy & Selection
  • ERP Integration
  • ERP Implementation
  • Workflow Mapping
  • System Design

AI & Automation

  • AI Workflow Automation
  • Machine Vision Verification
  • Barcode Verification
  • Inventory Automation
  • CRM & Workflow Automation

Data & Analytics

  • Pharmaceutical Data Warehousing
  • Business Intelligence Dashboards
  • AI Forecasting
  • Predictive Inventory Management
  • KPI & Performance Analytics
Patient in a telemedicine video consultation with a prescriber

11

Telemedicine Infrastructure

Provider networks, ePrescribing, and pharmacy fulfillment infrastructure.

Platform Development

  • Provider Networks
  • ePrescribing Integration
  • Pharmacy Fulfillment

Operations

  • Onboarding
  • Client Success
  • Fulfillment Optimization
Fulfillment team packing and labeling prescription orders at a shipping station

12

Operational Excellence

Lean operations and fulfillment optimized for capacity and throughput.

Lean Operations

  • KPI Development
  • Workflow Optimization
  • Labor Planning
  • Capacity Planning

Fulfillment

  • Pharmacy Fulfillment
  • Warehouse Design
  • Shipping Optimization
Pharmacy professionals in a hands-on compounding training session

13

Training Academy

Professional training across compounding, quality, regulatory, and leadership.

Professional Training

Compounding

  • USP 795
  • USP 797
  • USP 800

Quality

  • CAPA
  • Investigations
  • Auditing

Regulatory

  • FDA
  • DEA
  • Board of Pharmacy

Leadership

  • Operations Management
  • Facility Management
  • Scale-Up Strategy
Consultant and technician walking an automated tablet manufacturing line

14

Turnkey Pharmacy Solutions

Turnkey start-up and full deployment — from business plan to go-live.

Start-Up Services

New 503A Pharmacy

  • Licensing
  • Facility Design
  • Equipment
  • SOPs
  • Staffing

New 503B Facility

  • Facility Design
  • cGMP Systems
  • Equipment
  • Quality Systems

Full Turnkey Deployment

  • Business Planning
  • Facility Buildout
  • Equipment Procurement
  • Validation
  • Training
  • Regulatory Readiness
  • Go-Live Support
Who We Serve

Partners across the pharmaceutical ecosystem.

Telemedicine Companies
503A Pharmacies
503B Outsourcing Facilities
Drug Manufacturers
Wellness Brands
Veterinary Pharmacies
Specialty Pharmacies
Private Equity Firms
International Healthcare Companies
Get in touch

Let's Build What's Next.

Whether you're developing a new formulation, designing a sterile facility, scaling pharmacy operations, implementing ERP systems, or preparing for commercialization, Bains Consulting can help you move from concept to execution with confidence.

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