Navigate Regulatory Complexities with Confidence Through Our Support and Tailored Solutions
Understanding and adhering to life science’s regulatory affairs can be overwhelming for pharma companies. With constantly evolving requirements, vast regional requirements, and lengthy approval processes, bringing clinical products to market is filled with many roadblocks. This calls for third-party pharmaceutical regulatory affair service providers
ACL Digital Life Sciences understands these challenges and offers a wide range of innovative and advanced regulatory strategy consulting solutions to combat them. Our team of professionals can craft personalized regulatory strategies tailored to diagnostic tools and biological products. From early interactions with Health Authorities to seamless regulatory filings, we provide support to ensure timely approvals and successful market entry.
ACL Digital’s Advanced Regulatory Affairs Solutions for Industry Dominance and Competitive Advantage
Regulatory Consulting
Achieve statutory success with our expert regulatory consulting services, specializing in IDMP and IVDR. We offer practical and precise post-market compliance support and strategic guidance for clinical submissions.
- Expert guidance on regulatory frameworks
- Timely updates on regulatory intelligence
- Support for Health Authority queries
Regulatory Writing for Pharmaceuticals
We offer expert regulatory writing services for the pharmaceutical industry to help you submit statutory-complaint clinical documentation across critical eCTD modules. Our services range from developing Clinical Overviews (Module 2.5), Clinical Summaries (Module 2.7), and in-depth Clinical Study Reports (Module 5).
- Comprehensive development of eCTD modules
- Strategic support for regulatory labeling
- Strict adherence to regulatory standards
Regulatory Writing for Medical Devices
At ACL Digital, we specialize in regulatory writing for medical devices, ensuring your products meet global standards. We conduct thorough EU MDR Gap Analyses to pinpoint and resolve regulatory issues. Our UDI consulting guarantees accurate device identification and compliance.
- Thorough analysis to identify regulatory issues
- Expert crafting of Clinical Evaluation Plans
- Support for Post-Market Surveillance activities
Regulatory Consulting & Compliance
Why Choose ACL Digital’s Regulatory Affairs Services
Deep Regulatory Expertise
Comprehensive Service Offerings
Global Reach
Client-Centric Approach
Proactive Risk Management
Data-Driven Decisions
Client Impact
Effective Weather Data Monitoring and Analytics Solution
A leading global Industrial IoT manufacturer needed a real-time solution to collect, store, and analyze environmental sensor data. This would allow them to identify correlations between seemingly disparate data points, unlocking valuable insights.
The Challenges
- Absence of application to capture data from the sensors
- Lack of cloud-based ML solution
The Outcomes
- We provided upfront cost estimates using an AWS services calculator, preventing unnecessary spending.
- We helped upsell sensors by offering weather detection and prediction services through AWS Managed Services.
Voice-Based Gender Detection for Faster Product Launch
ACL Digital developed a voice-based gender detection application using machine learning for a leading US semiconductor company.
The Challenges
- Lack of innovative applications for new ML chipsets
The Outcomes
- Accelerated product launch by 20%
- Leveraged machine learning expertise
- Enhanced product value with voice-based gender detection
Smart Predictive Maintenance for Industrial Machinery
ACL Digital developed the IoTify framework on AWS IoT to provide intelligent preventive maintenance for a US-based industrial IoT company.
The Challenges
- Lack of AI/ML for early failure detection
- Need for customizable data dashboards
The Outcomes
- Saved 50% on R&D costs
- Gained a competitive edge with advanced predictive maintenance
- Improved efficiency and reduced downtime
