Regulatory Affairs & CMC

Strategic regulatory guidance from development to market authorization across EU and global markets

Our Regulatory Affairs Services

Marketing Authorization Applications

Complete MAA preparation and submission support for centralized, decentralized, and national procedures

  • Centralized Procedure (EMA) applications
  • Decentralized and Mutual Recognition procedures
  • National authorization pathways
  • Post-authorization commitments management

Clinical Trial Applications

CTA preparation and submission through CTIS and national competent authorities

  • Clinical Trial Information System (CTIS) submissions
  • Protocol and investigational medicinal product dossier
  • Ethics committee applications
  • Substantial amendment management

CMC Development & Strategy

Chemistry, Manufacturing, and Controls expertise for pharmaceutical development

  • CMC strategy and development planning
  • Quality target product profile (QTPP)
  • Manufacturing and analytical method development
  • Stability study design and data evaluation

Variation Management

Lifecycle management through post-authorization changes and variation submissions

  • Type IA, IB, and Type II variations
  • Extension applications
  • Line extensions and new indications
  • Annual re-assessment procedures

Regulatory Intelligence

Strategic insights and competitive intelligence for informed regulatory decision-making

  • Regulatory landscape analysis
  • Competitive intelligence and benchmarking
  • Guideline impact assessments
  • Regulatory pathway optimization

Health Authority Interactions

Expert representation and communication with regulatory agencies

  • Scientific advice meetings
  • Pre-submission meetings
  • Oral explanations and hearings
  • Inspector meetings and GMP inspections

EU Regulatory Pathways

Centralized Procedure

EMA

Single application for all 27 EU Member States through the European Medicines Agency

  • Mandatory for certain product types
  • Single marketing authorization
  • 210-day assessment timeline
  • Post-authorization single contact point

Decentralized Procedure

DCP

Simultaneous applications to multiple Member States for new marketing authorizations

  • Reference Member State coordination
  • Multiple national authorizations
  • 210-day assessment timeline
  • Streamlined multi-state approval

Mutual Recognition

MRP

Extension of existing national authorization to other EU Member States

  • Based on existing authorization
  • Reference Member State approach
  • 90-day assessment timeline
  • Cost-effective expansion

National Procedure

NAT

Direct application to individual national competent authorities

  • Country-specific requirements
  • Single market access
  • Variable assessment timelines
  • Local regulatory expertise

CMC Excellence & Quality by Design

Our CMC experts provide comprehensive support throughout the pharmaceutical development lifecycle, ensuring robust quality systems and regulatory compliance.

Quality Target Product Profile (QTPP)

Strategic definition of quality characteristics for optimal patient outcomes

Critical Quality Attributes (CQAs)

Identification and control of parameters essential for product quality

Design Space Development

Multidimensional combination of variables demonstrating process robustness

Control Strategy

Comprehensive approach ensuring consistent process performance

QbD
QTPP
CQA
Design Space
Control Strategy

Submission Process & Timelines

Pre

Pre-Submission Phase

Strategic planning, scientific advice, and dossier preparation

3-12 months
Sub

Submission & Validation

Application submission and formal validation by authorities

30 days
Ass

Assessment Phase

Scientific evaluation and potential questions/objections

210 days
Dec

Decision & Authorization

Final decision and marketing authorization grant

67 days

Accelerate Your Regulatory Success

Partner with our regulatory experts for streamlined market access and approval

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