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Pinnaql

Elevating Compliance. Empowering Innovation. Pinnaql helps life sciences companies bring safer, smarter therapies to market by integrating expert-driven solutions where precision and compliance matter most. They help pharma, biotech, and medical device companies overcome complexity, accelerate timelines, and stay audit ready by bringing deep technical, validation, and quality expertise to every stage of the product lifecycle.

  • Quality Management Systems – Pinnaql develops and maintains effective Quality Management System frameworks to reduce compliance risks and navigate regulatory complexities throughout your product lifecycle.

  • Quality Operations & Assurance – Pinnaql delivers integrated quality operations and compliance services. They combine technical engineers, lab scientists, and QA experts to develop systems that are technically sound, practical to execute, and built for global regulatory expectations.

  • Lab Technical Operations – Pinnaql delivers full-lifecycle lab operations support including instrument onboarding, equipment qualification and validation, workflow integration, data integrity, and software compliance so your scientific teams can focus on discovery.

  • Manufacturing Technical Operations – Pinnaql brings together engineering, validation, automation, and digital compliance to support the full product lifecycle from tech transfer to commercial production whether upgrading equipment, building a new line, or validating MES systems.

  •  Automation, AI and Digital Transformation - Pinnaql delivers automation and digital transformation services whether implementing robotics in fill/finish, advanced therapy lab & manufacturing automation, digitizing a batch record process, or rolling out predictive analytics.

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One Silver Serve

One Silver Serve, LLC* (OSS) operates as the SP Global Disaster Response Team (DRT) and is our inaugural Solutions Delivery Partner. With deep expertise in FDA‑regulated biopharmaceutical environments, BMRG and OSS provide nationwide coverage and rapid mobilization—arriving on‑site within two hours for most fire, water, wind, mold, and other damage‑related emergencies. This partnership helps minimize downtime and protect your critical operations.

Our alliance combines technically certified, highly experienced teams with the ability to scale up to 1,000 FTEs within 24 hours across the country. Backed by strong government relationships and more than $1 billion in completed construction projects, BMRG and OSS deliver proven, reliable response capabilities for our biopharma manufacturing clients.

 

In addition to emergency services, we offer preventive maintenance programs aligned with your existing standard operating procedures. Together, BMRG and OSS provide fully tailored, high‑touch solutions to support your ongoing maintenance and emergency recovery needs.

 

Select OSS Biopharma Manufacturing Projects

  • Top 15 Biopharma Company – Large water loss affecting mechanical, electrical, plumbing and storage rooms. 

  • Fully Integrated CDMO – Large roof fire loss causing extensive smoke damage in HVAC plenum areas and laboratories.  

  • Emerging Specialty Biopharma Company – Large HVAC fire loss causing heavy smoke throughout 125,000 square foot building.

  • Biopharma Analytics Lab – Large lab fire loss in a testing facility causing smoke and soot throughout the building. 

 

*One Silver Serve, LLC is an independently owned and operated franchise of Servpro Franchisor, LLC.

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LRC

From its inception, LRC Indoor Testing & Research has been grounded in scientific excellence. Co‑founder Dr. Eugene Cole — former Professor of Environmental Health Sciences at Brigham Young University and a key contributor to the industry’s remediation standards (IICRC S520 and S500) — helped establish the principles of accuracy and integrity that continue to guide their work today. Their team brings decades of combined expertise, with professionals holding advanced academic degrees in public health, microbiology, environmental science, chemistry, and related disciplines, along with respected industry certifications such as CMI, CMC, WRT, CAI, PMP, and the NEBOSH International General Certificate.

LRC staff includes licensed Registered Environmental Health Specialists, former university faculty, and specialists with advanced training in fungal microscopy and medical mycology at Harvard University and Emory University. With experience ranging from environmental laboratory management to service as a U.S. Army Environmental Safety Officer, their team is uniquely equipped to address complex indoor environmental challenges.

For BMRG clients, this means partnering with more than a comprehensive indoor environmental testing service provider — you gain access to a team built on scientific rigor, industry leadership, and a commitment to delivering clarity, accuracy, and trustworthy results in every assessment.

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Superior Mechanical

At Superior Mechanical, Inc. (SMI), they understand that pharmaceutical manufacturing demands precise, contamination‑controlled environments, which is why their team has deep expertise in designing, maintaining, and optimizing HVAC systems that meet FDA cGMP requirements for ISO‑classified cleanrooms. They properly engineer systems that are essential for controlling temperature, humidity, pressure differentials, and airborne particulates to prevent both viable and non‑viable contamination where required.

With more than 30 years of experience supporting commercial HVAC systems — including cleanrooms, sterile suites, and other regulated environments — SMI technicians service all major brands of pharmaceutical‑grade air handlers, HEPA/ULPA filtration units, and environmental control equipment to ensure validated, compliant performance.

As a Certified Linc Service® provider, SMI also delivers comprehensive preventative‑maintenance programs that help reduce energy costs, minimize the risk of unexpected system failures, and maintain the stable, compliant conditions essential for safe and consistent drug production.

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Citwell

Since 2010, Citwell has been a trusted partner to biopharma companies, helping secure business continuity, strengthen recovery capabilities, and optimize manufacturing operations — from R&D and clinical stages to multi-billion-dollar blockbuster medicines. With 100+ successful engagements, they deliver tangible impact across manufacturing, supply chain, and clinical operations, combining deep industry expertise with pragmatic execution. They have completed a multitude of biopharma projects.

  • Cyber recovery & business continuity programs across 20 manufacturing sites producing 12 critical products, leveraging a structured rescue approach and a five-level maturity model

  • SCOR® Class A assessments for rare-disease manufacturing sites, identifying critical gaps in operating processes, data, and systems — and supporting recovery to A-level performance with clear leadership roadmaps

  • Supply Chain & Manufacturing Planning transformation for R&D and CDMO sites, redesigning operating standards and re-engineering ERP processes to fit R&D-specific constraints

  • End-to-end clinical trial optimization, building prioritized improvement roadmaps across nine initiatives to reduce risk exposure and workload while accelerating execution

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