Regulatory Affairs Services

Faster Market Access Through Expert Regulatory Affairs

Navigating global regulatory requirements can be complex. At Kandula Pharmavigilence, we help pharmaceutical and healthcare companies achieve timely approvals while ensuring compliance with regulations across both regulated and emerging markets.

Our experienced regulatory team provides practical, reliable, and end-to-end support — from regulatory strategy and product registration to post-approval lifecycle management. We work closely with clients to develop customized solutions that meet country-specific requirements and accelerate market access.

Regulatory Affairs Services

Comprehensive Regulatory Affairs Services

Regulatory Strategy & Planning

  • Regulatory strategy and planning
  • New product registrations and marketing authorizations
  • Dossier compilation, review, and submission
  • Regulatory query (RFI) response management
  • Gap analysis and remediation
  • Regulatory due diligence
  • CMC (Chemistry, Manufacturing & Controls) advisory
  • API and Drug Master File (DMF) support

eCTD Publishing & Submission Management

  • eCTD publishing and validation
  • Global submission management
  • Legacy document conversion
  • SPL publishing
  • Electronic submission (e-Conversion)
  • Submission tracking and lifecycle management
  • Regulatory document management

Product Lifecycle Management

  • Product lifecycle management
  • Variations, renewals, and change control
  • Country-specific regulatory support (regulated & ROW markets)
  • Post-approval lifecycle management
  • Post-approval commitment management

Global Regulatory Submissions

  • US FDA submissions and liaison
  • EMA (European Medicines Agency) submissions
  • UK MHRA regulatory support
  • Saudi FDA submissions
  • TGA Australia regulatory support
  • Rest of World (ROW) market submissions

Why Choose Kandula Pharmavigilence?

Experienced Professionals

Our regulatory team comprises seasoned professionals with deep expertise in global regulatory requirements.

Regulated & Emerging Markets

We offer expertise across both regulated markets and emerging Rest of World (ROW) territories.

Tailored Regulatory Strategies

We develop customized, country-specific regulatory strategies to meet your unique product and market needs.

End-to-End Support

From regulatory strategy and dossier preparation through to post-approval lifecycle management.

Advanced eCTD Capabilities

We leverage advanced RIMS tools and best practices to streamline global electronic submissions.

Quality & Compliance Focus

Our focus on quality, compliance, and timely delivery ensures faster market access for your products.

Submissions to Major Regulatory Authorities

US FDA
EMA
UK MHRA
Saudi FDA
TGA Australia
ROW Markets

Our Other Services

Ready to Accelerate Your Market Access?

Partner with Kandula Pharmavigilence to simplify regulatory compliance, accelerate approvals, and successfully bring your products to global markets.

Get Regulatory Support