Accelerate Your Drug Development Timeline with Methodical Documentation Excellence
From IND to Commercial Launch - Trusted by biotech and pharma companies for 50+ years of proven regulatory documentation expertise
Why BioPharmaceutical Leaders Choose JANA Life Sciences
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ISO 9001:2015 as well as 13485:2016 certified processes ensure FDA compliance
Proven experience with Pfizer, Genentech, Amgen, Gilead
Managed 12+ regulatory filings (INDs, NDAs, sNDAs, BLAs, sBLAs)
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Multi-subsidiary system integration experience
8-week validation protocols (IQ, OQ, PQ)
21 CFR Part 11 compliance expertise
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20-35% below Big 4 consulting rates
Rapid deployment (proven 8-day turnaround capability)
Near-shore capabilities through JANA Mexico for additional savings
Complete BioPharmaceutical Documentation Solutions
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Service Categories
- Regulatory Documentation: Support related to INDs, NDAs, and BLAs, especially CMC sections and FDA correspondence
- Manufacturing Documentation: SOPs, work instructions, batch records, deviation investigations (CAPAs)
- LIMS Validation: Installation, operation, and performance qualification (IQ, OQ, PQ), validation protocols, audit-ready documentation
- Clinical Documentation: Study protocols, investigator brochures, clinical study reports
- Training Programs: GMP training, process documentation using TWI methodology
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Case Study Spotlight
Featured Success Story: Global Biotech Conglomerate LIMS Validation
- Challenge: 7 subsidiaries requiring integrated LIMS validation
- Solution: Comprehensive 8-week - validation with IQ, OQ, PQ protocols
- Results: Zero audit findings, streamlined operations across all facilities
- Quote: "JANA's methodical approach ensured our LIMS validation met all regulatory requirements while integrating seamlessly across our global operations."
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Regulatory Experience You Can Trust
- Leadership’s Background: 30+ years with Pfizer, Amgen, Genentech, and Gilead Sciences
- Project Portfolio: Avastin and Herceptin regulatory documentation support (among a dozen others)
- Global Experience: FDA, EMA, international regulatory requirements
- Compliance Record: Zero major audit findings in 50+ year company history
Essential Resources, Differentiation & Client Success
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Three Downloadable Resources
- LIMS Validation in 8 Weeks: Complete Guide (Based on biotech conglomerate success)
- FDA Submission Documentation Checklist (IND/NDA preparation guide)
- GMP Manufacturing Documentation Template Library (SOPs and batch records)
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Beyond Consulting - Your Strategic Documentation Partner
- vs. Big 4 Consulting: 25-40% cost savings
- vs. Technology Platforms: Human expertise that understands your science
- vs. Generalist Providers: Dedicated life sciences division with regulatory focus
- Family-Owned Advantage: Direct CEO access, long-term partnership approach
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Testimonials from BioPharm Clients
- Fortune 50 pharmaceutical CAPA mitigation success
- Global life science conglomerate 200+ training curricula
- Biotech LIMS validation testimonial
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What people are saying.
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Vice President, IT for a Mid-Sized BioTech Conglomerate
“I would like to thank you for your support and excellent work you and your team have performed so far.”
“You and your team have demonstrated thorough knowledge, excellent communication skills and have put in place a framework that allowed to minimize the ambiguous nature of some of our processes.”
“I truly looking forward to finalizing this project and discussing a future engagement.”
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Vice President, HR & IT for a Mid-Sized Pharma Company
“JANA has proven to be an invaluable partner in helping our company in three different areas, including clinical data management, operational excellence, and enterprise content management (ECM). As a result, we now have a much more complete understanding of our clinical development programs conducted over the years.”
“Operationally we have more consistent project timelines and project reporting as it pertains to our IT project portfolio, not to mention a better understanding of how our project review and approval process should work.”
“Best of all, we now have a robust ECM strategy, a comprehensive understanding of our current technology roadmap and a well thought out future state roadmap as well – not to mention all the deliverables needed to put these into motion, including stakeholder mappings, a risk register, and a program timeline.”
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Business Lead, IT for a Mid-Sized Pharma Company
“I wanted to take a moment to express my appreciation for the wonderful support during the integration...”
“Reminiscing how we started working together was in trying to come up with a standard methodology for small, medium and large projects. [At the same time] Trying to standardize a Project Management Methodology (PMI-based) that blended in ADKAR to ensure successful rollouts and adoption.”
“You have been a great support and ensuring that we did not drop the ball during the high-volume phase.”
“Thank you for your commitment and rigor. Wishing you the very best in your future endeavors.”
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Executive Director, Non-Profit Organization
“Ever since we completed it (75-page document) I've been sharing it with city councils, county commissioners, and state legislators.”
“Just yesterday I sent it to (governing official with name purposefully removed) and he really liked the resource, which he plans to use for talking points.”
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Executive Director, Regulatory Affairs, Mid-Sized Pharma
“Thank you for all your support and work! You have done a tremendous job here...”
“I wish you the very best in your future endeavors!”
“I know our paths will cross again!”
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Director, Project Management, Mid-Sized BioPharma
“Thanks right back for all the support and value you added in so many areas and so many ways, including mentoring!”