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Comprehensive CMC regulatory consulting services to support your pharmaceutical submissions.
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Own Label Supply (OLS) Variations
Own Label Supply variations are regulatory submissions required when pharmaceutical products manufactured at one site are distributed under different brand names by other marketing authorization holders. These variations ensure regulatory compliance when supply arrangements change.
Our Services Include:
- Type IA & IB Variation Support: Guidance on classification and submission requirements for OLS arrangements
- MHRA OLS Submissions: Specialized support for UK regulatory filings
- Documentation Preparation: Complete dossier compilation for OLS variation applications
- Agency Query Management: Expert responses to regulatory assessor questions
Common OLS Scenarios We Handle:
- Addition or deletion of manufacturing sites in existing OLS agreements
- Changes to packaging arrangements
- Updates to product specifications affecting multiple marketing authorizations
- Transfer of marketing authorizations with ongoing OLS commitments
Timeline: Type IA (30 days) | Type IB (60 days)
CMC Variations Services
CMC variations are required when changes occur to manufacturing processes, analytical methods, specifications, or facilities after a marketing authorization is granted. We help navigate the complexity of CMC regulatory submissions.
Our CMC Variation Expertise:
Manufacturing Changes
- Scale-up or scale-down of manufacturing processes
- Manufacturing site transfers and technology transfers
- Process optimization and equipment changes
- Introduction of alternative manufacturing routes
Analytical & Quality Changes
- Analytical method updates and validation
- Specification changes for drug substance and product
- Stability protocol modifications
- Container-closure system changes
API & Formulation Variations
- Active pharmaceutical ingredient (API) source changes
- ASMF (Active Substance Master File) updates
- Excipient specification modifications
- Formulation composition adjustments
Variation Types We Support:
- Type IA: Minor changes with no significant impact (30-day notification)
- Type IB: Changes requiring prior approval but less complex (60 days)
- Type II: Major changes requiring detailed assessment (90+ days)
eCTD Compilation Services
The eCTD format is the regulatory standard for pharmaceutical submissions to agencies worldwide. Our team ensures your submissions meet technical and content requirements for successful regulatory review.
What is eCTD?
The Electronic Common Technical Document (eCTD) is the internationally accepted format for preparing and submitting regulatory dossiers. It organizes information into five modules following ICH M4 guidelines.
Our eCTD Services:
Module Compilation
- Module 1: Regional administrative information and prescribing details
- Module 2: CTD summaries (Quality Overall Summary, Nonclinical/Clinical overviews)
- Module 3: Chemistry, Manufacturing, and Controls (CMC) documentation
- Module 4: Nonclinical study reports
- Module 5: Clinical study reports
Technical Services
- eCTD sequence creation and management
- Validation using official tools (Lorenz Validator, etc.)
- Lifecycle management for variations and updates
- Regional adaptation (FDA, EMA, MHRA, PMDA formats)
Agencies We Support:
Generic Drug Applications
Generic drug applications require demonstration of pharmaceutical equivalence and bioequivalence to the reference listed drug. Our regulatory expertise streamlines the approval pathway for generic products.
Generic Regulatory Services:
Pre-Submission Strategy
- Regulatory pathway determination (ANDA, Suitability Petition, 505(b)(2))
- Reference product analysis and paragraph selection
- Comparative dissolution study design
- Bioequivalence study planning
Application Preparation
- ANDA Compilation: Complete Abbreviated New Drug Application dossiers
- CMC Section Development: Drug substance and product characterization
- Comparative Quality Assessment: Side-by-side analysis with reference product
- Patent Certification: Paragraph I-IV patent strategy
Common Generic Categories We Handle
- Oral solid dosage forms (tablets, capsules)
- Injectable products
- Topical formulations
- Modified-release products
- Complex generics requiring additional clinical data
Success Rate: 95%+ first-cycle approval for complete submissions
Ready to Get Started?
Contact us to discuss your CMC regulatory needs and how we can support your submission strategy.
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