Purpose-built services for the regulated life sciences industry
Pinnaql empowers organizations across the life sciences industry with tailored, tech-enabled solutions to navigate regulatory complexity, accelerate innovation, and achieve operational excellence.
Built for the most demanding industries
From drug development to large-scale manufacturing, Pinnaql is more than a service provider — we’re a strategic partner with deep experience in the pharmaceutical, biotech, medical device, CDMO, and compounding pharmacy sectors. Our cross-functional teams integrate engineering, quality, and scientific expertise to help clients meet compliance demands, scale operations, and bring safe, effective products to market faster.
01
Engineering excellence
Equipment optimization, automation solutions, process validation, and utility systems designed with compliance in mind.
02
Scientific expertise
Analytical method development, laboratory system implementation, and seamless technology transfer expertise.
03
Quality assurance
Comprehensive regulatory strategy, QMS design, audit preparation, and effective CAPA implementation to ensure compliance.
04
Regulatory guidance
Built-in compliance with FDA. 21 CFR Part 210/211/820, ICH Q9/Q10, and ISO 13485.
We provide specialized expertise for every phase of the life sciences journey
Pinnaql delivers hands-on, specialized support across the most critical stage of your product lifecycle—from quality systems development and laboratory operations to validation, automation, and manufacturing execution. Our technical experts integrate seamlessly with your team, solving complex regulatory and operational challenges from the inside out.
Pharmaceutical manufacturing & compliance
Pinnaql offers comprehensive support for drug substance and drug product manufacturing, focusing on both large and small molecule processes. Our expertise includes aseptic processing, oral solid dosage (OSD), topical and semi-solid formulations, filling, packaging, and serialization. We ensure your operations meet stringent regulatory standards, optimizing production and maintaining quality throughout the product lifecycle.
Drug Substance & Product Manufacturing (bioreactors, chromatography, encapsulation lines)
Aseptic Processing (Class A/B/C cleanrooms, isolators, lyophilizers)
Small Molecule (OSD, topicals, semi-solids)
Filling, Packaging & Serialization (blister packaging, vision inspection, track & trace)
Advanced therapies: Biotech, Radiopharma, & CGT
Pinnaql supports the rapidly evolving field of advanced therapies, including biotech, radiopharmaceuticals, and cell & gene therapy (CGT). Our services cover specialized GMP compliance for radioactive drugs and the unique requirements of CGT manufacturing. We enable you to navigate the complexities of these cutting-edge therapies, accelerating development and ensuring patient safety.
Biotech: Bioreactors, purification systems, protein analytics
Radiopharma: Hot cells, shielded isolators, specialized dispensing systems
Cell & Gene Therapy: Vector production, cryopreservation, aseptic QC environments
Medical device assembly, packaging & compliance
We deliver automation, process validation, and compliance support for standalone devices and complex drug-device combinations — ensuring consistent quality and regulatory confidence.
Automated Assembly Lines & Vision Systems
Combination Products (auto-injectors, inhalers, drug-eluting stents)
Cleanroom Packaging & Labeling Systems
CDMO support from formulation to scale-up
Pinnaql provides comprehensive CDMO support to streamline drug development from early formulation through commercial scale-up. Our cross-functional team delivers integrated engineering, laboratory, and compliance services—spanning analytical development, tech transfer, GMP and CQV compliance, and process optimization. With deep industry expertise and proven methodologies, we help you navigate complexity, ensure regulatory alignment, and accelerate your path to market.
Analytical Development Laboratory asset solutions (HPLC, GC, MS)
Tech Transfer & Scale-Up Engineering
cGMP Engineering & Program Management Solutions
Facility Optimization & Compliance Systems
Compounding pharmacies: 503A & 503B
Pinnaql offers tailored support for 503A and 503B compounding pharmacies, from patient-specific compounding to large-scale sterile production. We ensure FDA compliance, optimize operations, and support QMS development, workflow software implementation, and strategic alignment to uphold the highest standards of safety and quality.
503A: Sterile Compounding (USP <797>, <800>, <795>), patient-specific workflows
503B: cGMP Compliance for Outsourcing Facilities
QMS Strategy, Workflow & SOP’s, Equipment CQV and Facility Design
End-to-End Compounding Support (formulation to automated packaging)
From lab development to manufacturing
Across the life science industry, Pinnaql delivers solutions that span the most critical steps of your product lifecycle from lab operations to tech transfer and manufacturing support.
Development & Formulation
Scale-Up & Tech Transfer
Manufacturing Optimization
Quality Systems & Validation
Post-Approval & Continuous Improvement
Let’s streamline, scale, and solve—together.
Whether you’re navigating a system implementation, preparing for an audit, or scaling operations, our team is ready to help. Share a few details, and we’ll connect you with the right experts.
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101 Lindenwood Drive, Suite 225, Malvern, PA 19355
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9800 Crosspoint Blvd, Suite 200, Indianapolis, IN 46256