Pinnaql strengthens scientific and manufacturing expertise with PRG acquisition.

Compliance-centric solutions for 503A & 503B compounding pharmacies

From patient-specific formulations to large-scale sterile manufacturing—Pinnaql helps compounding pharmacies meet FDA, USP, and cGMP standards with confidence.
Pharmacy lab compliance
Pharmaceutical compounding automation

Supporting pharmacy operations built on safety, sterility, and compliance

Whether operating as a 503A compounding pharmacy or a 503B outsourcing facility, your work exists at the intersection of precision, care, and quality. Maintaining sterility, managing facility risk, and complying with USP <797>, <795>, <800>, and FDA cGMP requirements is critical to patient safety and pharmacy success.

Pinnaql offers tailored support to help compounding pharmacies build scalable, audit-ready systems. From lab configuration and equipment validation to workflow optimization and quality system implementation, our team ensures your pharmacy is equipped to grow while remaining inspection-ready.

How we support compounding pharmacies

Pinnaql empowers compounding teams to operate safely, efficiently, and in full regulatory compliance

01

Tailored compliance programs

Support for USP <797>, <800>, <795>, and FDA cGMP standards.

02

Facility & equipment validation

Qualification of cleanrooms, isolators, autoclaves, and sterile prep systems.

03

Operational efficiency

Optimized compounding workflows, training, and SOPs for sustained compliance.

04

Scalable support for 503B growth

Strategy, QMS, and equipment support for large-scale sterile operations.

05

Digital transformation

Implementation of QMS and workflow software to support quality, traceability, and training.

Where we excel in pharmacy operations

Sterile compounding environment

503A compounding pharmacies – patient-specific

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We support individualized compounding operations with precision tools, validated workflows, and robust SOPs.
Laminar flow hoods, precision balances, sterile filtration units
Syringe pumps, capsule filling machines, ointment mills
pH meters, particle counters, compounding software
Compliance with USP <797>, <800>, <795>
Cleanroom and facility design; workflow optimization
GMP compliance monitoring

503B outsourcing facilities – large-scale

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Pinnaql equips 503B operations for growth with facility validation, cGMP compliance, and efficient high-volume production.
Automated vial/syringe filling and capping machines
High-volume mixing and blending systems
Industrial autoclaves, cleanroom monitoring systems
PAT tools, large-scale water purification systems
Validation of sterile systems and environmental controls

Our services

Explore our cross-functional solutions that support compounding pharmacy operations

Manufacturing technical operations

Engineering, scale-up, program management

Quality systems & lifecycle solutions

QMS development, eQMS, regulatory response

Quality operations & assurance

SOPs, CAPA, CQV, CSV

Lab tech operations & lifecycle services

Asset onboarding, validation, lab compliance

Automation, AI & digital transformation

Process automation, predictive monitoring

Let’s build a safer, more compliant compounding operation

Talk to our team about how Pinnaql can support your 503A or 503B pharmacy with practical, scalable, and audit-ready systems—from sterile prep to large-scale compounding.

Visit us

101 Lindenwood Drive, Suite 225, Malvern, PA 19355

Visit us

9800 Crosspoint Blvd, Suite 200, Indianapolis, IN 46256

Get in touch

(484) 321-3339