Innovation · Validation · Compliance

Cut through
complexity.
Deliver.

Specialized consulting for biopharma, data centers, and cGMP facilities. Inspection-ready outcomes, on time, every time.

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5+
Fortune 500
Companies
15+
Years of Industry
Experience
Global
SME Network Across
Key Markets
4+
Countries
Served
What we do

Deep expertise.
Real-world delivery.

We navigate you through the chaos — building structured frameworks for successful cross-functional collaboration.

From first-in-human to commercial scale, we embed alongside your team and own the outcome.

Process Engineering

Biopharmaceutical and medical device technology transfers, process development and scale-up and commercial launch.

  • Technology transfer across global regulatory jurisdictions
  • DoE-driven process development, CPV & continued process verification
  • Aseptic fill/finish, lyophilization, and commercial launch readiness
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Mission-Critical Program Delivery

Specialized project management for high tech / cGMP facility builds and validation, NPI orchestration, and operational readiness — on time, on budget.

  • High tech & cGMP facility CQV, integrated systems testing, and handover
  • NPI orchestration from concept through first commercial batch
  • Cross-functional alignment across engineering, quality, and operations
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Regulatory & Quality Assurance

Quality Assurance / Regulatory Affairs: QMS design and harmonization (ISO 13485, FDA QMSR, ICH Q10, 21 CFR 210/211), CMC strategy and authoring, contamination control strategy, remediation and DSCSA compliance.

  • Multi-site QMS harmonization and gap assessments
  • CMC strategy and authoring — IND, BLA, NDA, 510(k) submissions
  • Contamination control strategy, remediation planning, and DSCSA compliance
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Our ethos
Built by people
who've walked
in your shoes.

While Skapa was founded in 2025, our experts have earned their title through years of accomplishment — many have worked in industry and witnessed firsthand the challenges of complex drug development. Through our knowledge, skill, and passion, we enable clients to create and manufacture life-impacting products around the world.

"Deliver life-saving products and mission-critical programs — inspection-ready, on time, on budget, compliant."

Team collaborating in a bright modern workspace
5+
Fortune 500 clients
SKAPA_AI — Coming Soon

Intelligent compliance.
Always current.

We're building an AI-powered platform that automates compliance workflows, harmonizes QMS documentation, and packages next-generation commissioning deliverables — so your team focuses on science, not paperwork.

  • ✓ Intelligent Quality Systems and SOP harmonization across sites
  • ✓ Next-generation Commissioning and Validation packaging
  • ✓ Real-time gap analysis and rapid adoption to evolving regulatory frameworks
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skapa-qms / compliance-monitor
QMS COMPLIANCE DASHBOARD ● LIVE
▣ CAPA Management 21 CFR 820 ✓
▣ Change Control ICH Q10 ✓
▣ Supplier Qualification Review ⚠
▣ EU MDR Gap Analysis AI Drafting…
Overall Compliance Score 78 / 100
3 items require attention · Last scan: 2m ago
Get in touch

Ready to get it done?

No sales theater. A real human follows up within one business day with scope, timeline, and next steps.

  • ✓ Industry veterans, not theorists. We've shipped PPQ batches and launched into global markets.
  • ✓ Comprehensive services across Biopharma, Med Devices, Data Centers, and cGMP Facilities.
  • ✓ Cost-effective solutions tailored to your needs. Outcome-driven. On time.
  • ✓ Global reach with local expertise — 4+ countries served.
[email protected]
+1 (512) 730-1346
Austin, TX · Mon–Fri 7AM–6PM EST

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