How Nextyn Helped a Global Pharma Company Understand Evolving Regulatory Policies

Executive Summary

A global pharmaceutical company was preparing to launch a new drug in multiple international markets but faced regulatory uncertainty due to evolving compliance requirements across different regions.

To ensure a smooth approval process, the company needed expert insights on:

• Recent changes in regulatory frameworks (FDA, EMA, MHRA, TGA).
• Best practices for drug approval submissions in key markets.
• Clinical trial data requirements for each region.
• Potential compliance risks and mitigation strategies.

To address these challenges, the company engaged Nextyn’s Expert Calls service to connect with former regulators, compliance officers, and market access specialists for real-time insights.

• 20+ pharmaceutical regulatory experts onboarded within 72 hours for direct consultations.
• Expert calls covering approval timelines, documentation expectations, and compliance risks.
• AI-powered transcript storage, enabling structured insights for internal reporting.

With these expert interactions, the pharmaceutical company refined its regulatory strategy, ensuring a faster and smoother approval process across multiple markets.

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Client Profile & Challenges

Client Profile:

• Industry: Pharmaceutical & Biotechnology
• Project Focus: Understanding Evolving Drug Approval Regulations
• Target Audience: Regulatory affairs teams, compliance officers, legal advisors

Challenges Faced by the Pharma Company:

• Regulatory Uncertainty Across Markets: The company needed to navigate different approval processes across the U.S., EU, U.K., Australia, and APAC.
• Changing Compliance Requirements: With recent policy shifts in drug safety and clinical trials, staying compliant was becoming increasingly complex.
• Clinical Trial & Data Submission Concerns: Each region had different requirements for trial data submission and reporting.
• Avoiding Regulatory Delays & Market Entry Risks: A compliance error could lead to approval delays or even product rejection.

Without real-time insights from regulatory experts, the company risked costly submission mistakes and delayed market access.

Nextyn’s Solution

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Fast & Precise Expert Calls

Nextyn identified and engaged 20+ pharmaceutical regulatory experts within 72 hours, ensuring:

• No conflicts of interest or outdated perspectives.
• Unfiltered insights from former regulators, legal specialists, and industry leaders.
• Region-specific compliance expertise to address each market’s unique approval process.
• All calls conducted under NDAs to protect proprietary drug information.

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• Expert Calls Covering Key Regulatory Areas
  • Recent Regulatory Changes & Compliance Updates
    • Former FDA, EMA, and MHRA regulators provided insights into new policy shifts affecting drug approvals.
  • Clinical Trial Submission Requirements & Market-Specific Variations
    • Clinical data specialists explained how trial results must be formatted and submitted for approval in different regions.
  • Risk Mitigation Strategies & Common Regulatory Pitfalls
    • Pharmaceutical compliance experts outlined how companies can avoid submission rejections and accelerate approvals.
  • Best Practices for Multi-Market Drug Registration
    • Regulatory affairs executives from top pharma companies shared successful strategies for global drug registration.

• AI-Powered Call Management & Data Storage
  • All calls were recorded and transcribed in Nextyn’s AI-driven dashboard.
  • Clients could search, summarize, and extract key insights instantly.
  • Nextyn structured the insights into a customized compliance report, making it easy for the client’s regulatory team to implement findings.

Sample Expert Profiles

Expert 1: Former FDA Regulatory Affairs Officer (Ex-FDA, Center for Drug Evaluation & Research)

• Experience: 18+ years in drug approval & compliance.
• Relevance: Provided guidance on U.S. FDA approval processes and post-market surveillance requirements.

Expert 2: EMA Compliance & Market Access Expert (Ex-European Medicines Agency, Drug Authorization Division)

• Experience: 20+ years in pharmaceutical regulation and European drug market entry.
• Relevance: Shared insights on recent changes to EU drug approval frameworks.

Expert 3: TGA & APAC Regulatory Consultant (Ex-TGA, Australian Drug Evaluation Unit)

• Experience: 15+ years in Australia & Asia-Pacific compliance policies.
• Relevance: Advised on TGA approval steps and key documentation requirements.

Expert 4: Clinical Trial Data & Reporting Specialist (Ex-Novartis, Regulatory Data Compliance Head)

• Experience: 14+ years in clinical data standardization and trial reporting.
• Relevance: Explained how to structure clinical trial results to meet multi-market submission standards.

Expert 5: Global Pharma Compliance Director (Ex-GlaxoSmithKline, Regulatory Affairs Lead)

• Experience: 16+ years in global pharmaceutical market expansion.
• Relevance: Shared best practices for coordinating regulatory submissions across multiple regions.

Impact & Results

• Regulatory Strategy Refined with Expert Insights: The pharma company adjusted its submission process to align with updated global policies.
• Avoided Compliance Pitfalls & Approval Delays: Experts highlighted potential submission risks, helping the client prevent regulatory setbacks.
• 20+ Expert Calls Conducted in 10 Days: Delivering real-time, market-specific regulatory insights.
• 50% Faster Market Access Strategy: The company streamlined its approval process, cutting expected submission review time by half.

Thanks to Nextyn’s expert calls, the pharmaceutical company successfully prepared for regulatory approvals, avoiding costly delays and compliance errors.

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Key Benefits of Using Nextyn’s Expert Calls

• Speed & Compliance Expertise: Former FDA, EMA, and TGA regulators onboarded within 72 hours.
• Real-Time Regulatory Insights: Direct engagement with industry-leading regulatory specialists.
• AI-Powered Data Management: Clients could search and analyze expert transcripts instantly.
• Confidential & Compliance-Assured Calls: NDAs and ethical research guidelines maintained strict confidentiality.