Our Expertise

Services

Comprehensive regulatory consulting services spanning product registration, CMC evaluation, AI integration, and strategic advisory.

Core Services

SFDA & GCC Regulatory Services

Our regulatory team brings deep expertise in SFDA and GCC authority requirements, ensuring your products navigate the approval process efficiently and successfully.

Global regulatory network

Drug Registration

  • Innovative Drugs
  • Generic Drugs
  • Biosimilars

Biologics & ATMPs

  • Biological Products
  • Advanced Therapy Medicinal Products
  • Cell & Gene Therapy

Medical Devices & IVDs

  • Device Classification
  • Technical Documentation
  • IVD Registration
Technical Excellence

CMC Evaluation & Dossier Support

Our CMC experts ensure your Chemistry, Manufacturing, and Controls documentation meets the highest regulatory standards.

Module 3 Gap Analysis

Comprehensive review of your CMC dossier against current regulatory expectations, identifying gaps and providing actionable remediation plans.

Comparability Assessments

Expert evaluation of manufacturing changes and their impact on product quality, safety, and efficacy with full regulatory documentation.

Stability Strategy

Design and review of stability programs aligned with ICH guidelines and regional requirements for SFDA and global submissions.

Advanced Consulting

AI & Strategic Advisory

AI in Regulatory Workflows
Implementation of AI-powered tools for document review, submission automation, and regulatory intelligence gathering.
Regulatory Strategy Design
Bespoke regulatory strategies for complex products, including pathway selection, submission planning, and authority engagement.
Due Diligence
Regulatory due diligence for M&A, licensing deals, and strategic partnerships — assessing regulatory risk and opportunity.
AI-powered consulting
Transparent Pricing

RAIRF Pricing Tiers

Our Risk-Adjusted Intelligent Regulatory Fee model ensures transparent, complexity-aligned pricing across all product categories.

Tier 1
Low
Simple device listing, generic drug
15K – 30K USD
Tier 2
Medium
IVD, generic with complex formulation
40K – 90K USD
Tier 3
High
Biologics, biosimilar
120K – 250K USD
Tier 4
Strategic
AI / Policy / novel ATMP
250K+ USD

RAIRF Formula: Base Fee × Pathway Factor × Risk Multiplier × Scope Adjustment + Add-ons

Risk multipliers range from 1.0x (low risk) to 2.2x (critical risk) based on 6 regulatory, technical, and commercial risk factors

Service Catalog

Download Our Complete Service Catalog

Get a comprehensive overview of all PEARA services, pricing tiers, engagement models, and training programs in a single client-ready document.

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Service
Catalog
2026

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