Regulatory Affairs Experts for the Pharmaceutical Industry
Empowering pharmaceutical companies with end-to-end regulatory guidance — from strategic planning and compliance management to global submission support.
Guiding life sciences through every regulatory pathway with clarity, compliance, and confidence.
We partner with pharmaceutical companies globally — bridging the gap between regulatory intelligence and the operational activities associated with compliance.
Regulatory Dossier Review & Management
Novalence provides structured support for the preparation, review, and organization of regulatory dossiers including CTD, ACTD, and DMF formats. Our services ensure that documents are properly structured according to regulatory requirements, enabling efficient review, compliance verification, and submission readiness.
We assist clients in navigating regulatory documentation with clarity, accuracy, and confidentiality while ensuring alignment with international regulatory expectations.
✦Key Features Include
- ▸Structured preparation of CTD and ACTD modules
- ▸Comprehensive dossier review for regulatory compliance
- ▸Document organization and formatting according to submission standards
- ▸Confidential handling of regulatory data and documents
- ▸Support for regulatory submissions and lifecycle documentation
Seasoned professionals with deep Pharmaceutical Regulatory Affairs expertise
Project leads hold MPharm in Regulatory Affairs or a Doctorate in a relevant field
Supporting regulatory strategy across multiple international markets
Full Suite of Service Offerings
Comprehensive regulatory support across the entire product lifecycle — from first submission to post-marketing.
Regulatory Documentation
- ▸CTD Dossier Compilation
- ▸ACTD Dossier Formatting
- ▸Regulatory Document Editing and Review
Quality & Compliance
- ▸SOP Drafting
- ▸Stability Documentation
- ▸DMF Documentation & Compilation Support
- ▸CDP study/ evaluation
Regulatory Support
- ▸Labeling & Artwork Review
- ▸Regulatory Gap Analysis
- ▸Regulatory Research
Experienced Regulatory Support for the Pharmaceutical Industry
Delivering expert-led regulatory solutions that help pharmaceutical companies meet compliance standards and achieve successful submissions.
Efficiency
- ▸Streamlined regulatory documentation processes.
- ▸Faster dossier preparation and project turnaround.
- ▸Clear communication and dedicated project coordination.
- ▸Single point of contact for efficient project management.
Experience
- ▸Strong knowledge of pharmaceutical regulatory documentation.
- ▸Expertise in CTD / ACTD dossier compilation.
- ▸Experience with stability documentation and SOP preparation.
- ▸Understanding of global regulatory submission requirements.
Cost Reduction
- ▸Cost-effective outsourcing for regulatory documentation.
- ▸Reduced operational burden for pharmaceutical companies.
- ▸Flexible service models based on project requirements.
- ▸High-quality regulatory support at competitive pricing.
Flexibility & Trust
- ▸Reliable regulatory documentation and compliance support.
- ▸Transparent communication throughout the project lifecycle.
- ▸Commitment to accuracy, quality, and regulatory standards.
- ▸Trusted partner for pharmaceutical and nutraceutical companies.
Our Regulatory Approach
A structured, end-to-end process designed to ensure every submission is accurate, compliant, and ready on time.
Understanding Your Product
Review of product information and regulatory requirements.
Regulatory Strategy Planning
Identifying the appropriate regulatory pathway for submission.
Documentation Preparation
Structured preparation of CTD / ACTD and supporting documents.
Quality & Compliance Review
Ensuring documentation aligns with regulatory standards.
Submission Readiness
Final verification before regulatory submission.
Client Collaboration
Continuous communication and project coordination.
Helping You Navigate Your Regulatory Challenges
We have the knowledge and expertise to navigate the most complex pharmaceutical regulations — ensuring full global compliance throughout every step.
