Regulatory Services

“Expert Global Regulatory Dossier Services: Streamlining Your Path to Market Approval

In the complex landscape of international regulatory compliance, preparing comprehensive and accurate dossiers is crucial for obtaining product registration and market access. Our team of experts specializes in crafting high-quality global regulatory dossiers that meet the stringent requirements of various countries, ensuring a seamless approval process.

Our comprehensive services include:

Regulatory strategy development and guidance
Dossier preparation and compilation
Document review and validation
Compliance assessment and risk management
Submission and liaison with regulatory authorities
Post-submission support and query resolution
By leveraging our expertise, you can:
Ensure accuracy and completeness of dossiers
Avoid costly discrepancies and delays
Expedite market approval and product launch
Enhance your global regulatory reputation
Stay up-to-date with evolving regulatory requirements

Our extensive knowledge of country-specific regulations and guidelines enables us to tailor our services to meet the unique needs of each market, including:

FDA (USA)
EMA (EU)
MHRA (UK)
TGA (Australia)
CFDA (China)
ANVISA (Brazil)
WHO (Global) SPECIFIC GUIDELINE
⁠ICH – WORLDWIDE GUIDELINES – CTD 05 MODULES⁠
ASEAN GUIDELINES – ACTD 04 PARTS

Trust us to navigate the intricate world of global regulatory compliance, ensuring your products reach new markets efficiently and effectively.”