“PDFelement isn’t just software—it’s our compliance co-pilot. From ensuring millimeter-perfect margin alignment in dossiers to securing cross-border data flows, it’s redefined how we scale quality in a regulated world.”
Tingwei
Senior Manager
Lotuspharm is a multinational pharmaceutical leader headquartered in Singapore, specializing in oncology drug development and regulatory compliance across 15+ Asian and European markets. With 80% of its operations involving cross-border clinical trial documentation and multi-language regulatory submissions, the company faced mounting pressure to streamline its document workflows. Industry context amplifies these challenges: 72% of APAC pharmaceutical companies report delayed approvals due to non-compliant documentation, while 65% struggle with multi-language translation accuracy in FDA/EMA submissions. Lotuspharm sought a solution to unify compliance, security, and multilingual efficiency in its document lifecycle.
Challenges
Lotuspharm, as a leading company in the industry, is also very cautious in handling document data. Lotuspharm often encounters several problems:
- Compliance Risk: Manual proofreading of 200+ page clinical trial reports led to inconsistencies in FDA/EMA formatting standards, with 12% of submissions requiring costly revisions.
- Multi-Language Bottlenecks: Translating drug dossiers into 8+ languages (e.g., Japanese PMDA, China NMPA) consumed 30% of regulatory teams' time, exacerbated by legacy tools’ limited OCR accuracy for handwritten lab notes.
- Collaboration Fragmentation: Secure redaction and version control issues arose when coordinating with CROs (Contract Research Organizations), delaying critical approvals by up to several weeks. Additionally, rising IT costs from maintaining disjointed PDF editors and translation plugins strained budgets, with legacy systems costing 40% more than industry benchmarks.
Solutions
Lotuspharm implemented Wondershare PDFelement to revolutionize its document ecosystem:
1. AI-Powered Compliance Guardrails:
- Deployed batch AI grammar checks to auto-validate clinical reports, reducing formatting errors by 90%. Created custom compliance templates for HSA submissions, integrating split-view editing to compare draft vs. regulatory guidelines in real time.
2. Multi-Language OCR & Translation Synergy
- Scanned 1,000+ pages of lab data using PDFelement’s enhanced OCR, achieving 98% accuracy in character recognition.Streamlined translations via integrated AI glossaries, cutting dossier preparation time from 14 days to 72 hours.
Results
The partnership with Wondershare delivered quantifiable breakthroughs:
Clinical trial report approvals accelerated by 50%, with AI-driven error detection saving 400+ hours/year in manual reviews.Reduced translation costs by 45% through OCR automation, while secure annotation workflows slashed CRO feedback cycles from 21 days to 5 days. This transformation positioned Lotuspharm as a pioneer in APAC’s pharmaceutical digitalization.
Conclusion
“PDFelement isn’t just software—it’s our compliance co-pilot. From ensuring millimeter-perfect margin alignment in dossiers to securing cross-border data flows, it’s redefined how we scale quality in a regulated world.”
—— Tingwei, Senior Manager
