Regulatory Management (Overview)
Regulatory management is not just about tracking legislation. It requires managing data, documentation, and processes together to protect your products' market access. Pier Compliance provides end-to-end regulatory management without building a separate department; from scope analysis of your product portfolio to supply chain documentation, from SDS/label/technical file coordination to audit readiness.
Why "Regulatory Management"?
Regulations constantly change: scope expands, formats update, audit expectations increase.
Compliance costs multiply when delayed: penalties, delivery delays, customer loss, and rework.
Good regulatory management sees risks early, standardizes operations, and makes costs predictable.
What do we cover? (example service modules)
1) Portfolio & scope analysis
• Product/substance/country-based obligation mapping
• Role identification (manufacturer/exporter/importer/downstream)
• Risk and prioritization
2) Documentation and data chain management
• Evidence pack and revision management
• Supplier data requests, format standards
• Traceable record system
3) Product compliance coordination (single point)
• SDS/label/CLP/SEA control flows
• Technical files and product safety documentation
• Market entry packages (aligned with customer requirements)
4) Audit readiness and internal control
• Checklists, responsibility matrix (RACI)
• Gap audit and corrective action plan
• File structure for "quick response" in audits
5) Change management
• Regulatory update tracking and impact analysis
• Product formula/label/supplier change scenarios
• Continuous compliance calendar (monthly/quarterly)
Pier Compliance working model
Single point of contact: coordination of all compliance work in one hand.
Regular reporting: weekly/monthly compliance status, open actions, deadlines.
Actionable templates: data forms, checklists, evidence files.
Quick action: prioritization in critical customer/audit requests.
Concrete deliverables
• Compliance scope map + risk matrix
• Documentation/evidence file structure (versioned)
• Standard checklists and workflows
• Supplier data packages and tracking table
• Regular compliance reports (monthly/quarterly)
• Audit readiness file and corrective action plan
When is it needed?
• New product launch to EU/Turkey market
• Multi-country / multi-product portfolio growth
• Approaching customer audit or official audit
• Supplier change / formula change / label revision
• Need for resources to "manage compliance work in one hand"
Pier Compliance Regulatory Management Service Scope
Comprehensive regulatory management service package:
- Scope/country/product compliance strategy and roadmap
- Supply-chain data & documentation control (evidence, versioning)
- Single-point coordination for SDS/labels/technical files
- Audit readiness: checklists, internal controls, traceable records
- Change management: regulatory updates, product/supplier changes
- Operational deliverables: weekly/monthly compliance reporting
Why Pier Compliance?
- Single point of contact: coordination of all compliance work in one hand
- Regular reporting: weekly/monthly compliance status, open actions, deadlines
- Actionable templates: data forms, checklists, evidence files
- Quick action: prioritization in critical customer/audit requests