Regulatory Compliance Consulting

𝗪𝗵𝗮𝘁 𝗜𝘀 𝗣𝗿𝗼𝗹𝗶𝗳𝗲𝗿𝗮𝘁𝗶𝗼𝗻 𝗙𝗶𝗻𝗮𝗻𝗰𝗶𝗻𝗴? Money laundering and terrorist financing often dominate compliance conversations. But have you noticed that recently governments are highly concerned about proliferation financing? 𝗣𝗿𝗼𝗹𝗶𝗳𝗲𝗿𝗮𝘁𝗶𝗼𝗻 𝗳𝗶𝗻𝗮𝗻𝗰𝗶𝗻𝗴 refers to the financial support provided to individuals, organizations, or activities involved in developing, producing, or delivering weapons of mass destruction (WMDs). These funds can flow through legitimate business channels or illegal networks. Although the FATF Recommendations cover money laundering, terrorist financing, and proliferation financing, the latter often receives less attention by both, countries and regulated entities. 𝗙𝗔𝗧𝗙 𝗥𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀 𝗳𝗼𝗿 𝗣𝗿𝗼𝗹𝗶𝗳𝗲𝗿𝗮𝘁𝗶𝗼𝗻 𝗙𝗶𝗻𝗮𝗻𝗰𝗶𝗻𝗴 Recommendation 7 highlights its importance, requiring countries to implement UN Security Council sanctions. This involves freezing assets and preventing funds from being made available to individuals or entities involved in WMD proliferation. 𝗪𝗵𝗮𝘁 𝗺𝘂𝘀𝘁 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗲𝗱 𝗲𝗻𝘁𝗶𝘁𝗶𝗲𝘀 𝗱𝗼? Organizations, including financial institutions, DNFBPs, and virtual asset service providers, must consider proliferation financing measures which include: ↳ 𝗜𝗱𝗲𝗻𝘁𝗶𝗳𝘆𝗶𝗻𝗴 𝗮𝗻𝗱 𝗮𝘀𝘀𝗲𝘀𝘀𝗶𝗻𝗴 𝗿𝗶𝘀𝗸𝘀: Understand their exposure to proliferation financing. This includes analyzing their customer base, the countries they operate in, the products and services they offer and the strength of their internal controls. => Document your assessments. ↳ 𝗦𝗰𝗿𝗲𝗲𝗻𝗶𝗻𝗴: Establish comprehensive sanctions screening systems to screen customers against UN sanctions lists. Enusre timely updates to these lists and incorporate changes into your screening processes. => Consider tools that utilize machine learning to improve the effectiveness of screening. ↳ 𝗗𝘂𝗲 𝗱𝗶𝗹𝗶𝗴𝗲𝗻𝗰𝗲: Implement robust KYC procedures to identify and verify customers. Conduct enhanced due diligence where necessary, especially for customers dealing in high-risk sectors or those exhibiting suspicious activities. => Understand the beneficial ownership of companies and scrutinize complex structures. ↳ 𝗧𝗿𝗮𝗻𝘀𝗮𝗰𝘁𝗶𝗼𝗻 𝗺𝗼𝗻𝗶𝘁𝗼𝗿𝗶𝗻𝗴: Implement transaction monitoring systems to detect unusual or suspicious activities that could indicate sanctions evasion. Pay close attention to transactions involving high-risk jurisdictions, dual-use goods, shell companies and complex financial flows. => Report any suspicious transactions to relevant authorities. Does your AML/CFT program incorporate measures to mitigate proliferation financing risks?

Understanding Drug Approval Process in the European Market. I’ve created this document to provide a clear, structured overview of EU drug approval pathways, including key procedures like 📌 Centralized Procedure (via EMA) 📌Decentralised Procedure (DCP) 📌Mutual Recognition Procedure (MRP) 📌National Procedure (NP) 📌Interview Q&A specifically prepared to help regulatory professionals and students get job-ready. This guide is ideal for: 🎯 Regulatory Affairs professionals 🎯 Pharma students preparing for interviews 🎯 Anyone looking to understand the EU regulatory landscape with clarity and real-world examples 🧠 It also includes detailed flowcharts, case examples, and references to EMA & HMA guidelines. #RegulatoryAffairs #PharmaRegulations #DrugApproval #EMA #EUMarketAccess #DecentralisedProcedure #MutualRecognitionProcedure #ClinicalTrials #PharmaceuticalIndustry   #InterviewPreparation #RegulatoryJobs #HealthcareRegulation #PharmaCareers #LinkedInLearning #RegulatoryStrategy #SarveshBari #DrugApproval #CentralisedProcedure #MRP #EUCompliance  #qualityassurance #HealthcareRegulation #DrugDevelopment #MedicinesRegulation

𝗛𝗼𝘄 𝘁𝗼 𝗯𝘂𝗶𝗹𝗱 𝗦𝘂𝗰𝗰𝗲𝘀𝘀 𝗶𝗻 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗖𝗮𝗻𝗻𝗮𝗯𝗶𝘀. 𝗪𝗶𝘁𝗵𝗼𝘂𝘁 𝗕𝘂𝗿𝗻𝗶𝗻𝗴 𝗖𝗮𝘀𝗵 𝗼𝗿 𝗖𝗿𝗲𝗱𝗶𝗯𝗶𝗹𝗶𝘁𝘆 Start with the Patient, Not the Plant Medical cannabis is medicine, not wellness or lifestyle. Your product must serve a real need consistently & safely, backed by data. Understand patient journeys, work with clinics & doctors, & embed yourself in the healthcare system, not outside it. Build GACP First, Then EU GMP or Equivalent Too many try to chase EU GMP without mastering GACP. Good Agricultural & Collection Practices are about how you grow. EU GMP is for post-harvest processing & pharma-grade quality control. Get the basics right, document everything, & then scale. Make Regulation One of Your Strengths If you don’t understand the regulatory landscape, you don’t have a business. Know your country’s cannabis laws, narcotics classifications, export rules, & patient access pathways. Compliance is not a department, it’s part of your product. Never Outsource Your Integrity There will be pressure to cut corners, overpromise, or take shortcuts. Don’t. One contamination, one false claim, one deal with a bad distributor and your business collapses. In cannabis, reputation takes years to build and seconds to lose. Trust the Local Team If you operate in another country, listen to the people on the ground. Local growers, engineers, regulators, and logistics teams know more than a remote HQ ever will. Many failed projects stem from ignoring local intelligence. Control the Supply Chain Medical cannabis isn’t just about growing. It’s about controlling drying, processing, lab testing, packaging, export clearance, & more. Own your chain or verify every part of it. You cannot afford surprises with patient-use products. Avoid Chasing the “Next Big Thing” There’s always a new hype, CBD for pets, infused snacks, luxury creams. These trends rarely survive strict medical regulation. Stick to your core business. Deliver clean, consistent, compliant flower or extract. Then grow. Document Everything This industry runs on traceability. You need clean SOPs, batch logs, validated results, cultivation records, & patient outcomes. If it’s not documented, it didn’t happen. If it’s not auditable, it’s not exportable. Raise the Right Money Work with investors who understand the timelines and risks. You need partners who can handle a 3 to 5-year return horizon and still back compliance over short-term revenue. Misaligned finance will kill your project faster than pests. Know When to Say No Sometimes the smartest move is to walk away. If the laws are too grey, your partners untrustworthy, or the facility isn’t ready, pause. Medical cannabis must be built with discipline and maturity. Forced projects fail. Focused ones succeed. Please ask me how to build or fix your cannabis business if you are unsure, stuck, or scaling. I’ve worked in this space for 9+ years, and I have seen what works and what wrecks good ideas.

As a lawyer who often dives deep into the world of data privacy, I want to delve into three critical aspects of data protection: A) Data Privacy This fundamental right has become increasingly crucial in our data-driven world. Key features include: -Consent and transparency: Organizations must clearly communicate how they collect, use, and share personal data. This often involves detailed privacy policies and consent mechanisms. -Data minimization: Companies should only collect data that's necessary for their stated purposes. This principle not only reduces risk but also simplifies compliance efforts. -Rights of data subjects: Under regulations like GDPR, individuals have rights such as access, rectification, erasure, and data portability. Organizations need robust processes to handle these requests. -Cross-border data transfers: With the invalidation of Privacy Shield and complexities around Standard Contractual Clauses, ensuring compliant data flows across borders requires careful legal navigation. B) Data Processing Agreements (DPAs) These contracts govern the relationship between data controllers and processors, ensuring regulatory compliance. They should include: -Scope of processing: DPAs must clearly define the types of data being processed and the specific purposes for which processing is allowed. -Subprocessor management: Controllers typically require the right to approve or object to any subprocessors, with processors obligated to flow down DPA requirements. -Data breach protocols: DPAs should specify timeframes for breach notification (often 24-72 hours) and outline the required content of such notifications, -Audit rights: Most DPAs now include provisions for audits and/or acceptance of third-party certifications like SOC II Type II or ISO 27001. C) Data Security These measures include: -Technical measures: This could involve encryption (both at rest and in transit), multi-factor authentication, and regular penetration testing. -Organizational measures: Beyond technical controls, this includes data protection impact assessments (DPIAs), appointing data protection officers where required, and maintaining records of processing activities. -Incident response plans: These should detail roles and responsibilities, communication protocols, and steps for containment, eradication, and recovery. -Regular assessments: This often involves annual security reviews, ongoing vulnerability scans, and updating security measures in response to evolving threats. These aren't just compliance checkboxes – they're the foundation of trust in the digital economy. They're the guardians of our digital identities, enabling the data-driven services we rely on while safeguarding our fundamental rights. Remember, in an era where data is often called the "new oil," knowledge of these concepts is critical for any organization handling personal data. #legaltech #innovation #law #business #learning

I had to share this FERMÀT customer story because it is about reinventing compliant growth in a highly regulated space. 1906, pioneers in functional cannabis, faced a classic innovator's dilemma. They had built an incredible brand around precision-engineered products, but Meta's strict regulations were creating a growth ceiling. Here's how they architected AI-powered FERMÀT experiences that balanced compliance with scalability: 1. Compliant Journey Architecture → Leveraged subdomain infrastructure for platform-friendly landing experiences → Implemented two-click age verification without disrupting flow → Created seamless post-verification product discovery 2. Educational Content Engineering → Built embedded product detail pages that preserved brand identity → Developed compliance-first but conversion-optimized content paths → Maintained rich product education without compromising ad policies 3. Dynamic Campaign Frameworks → Designed seasonal bundle architectures → Executed a brilliant Dry January campaign, repositioning their best-selling bundle as an alcohol alternative → Saw a 45% lift in AOV through this strategic timing and positioning The results? • 98% lift in overall conversion rate (outperforming industry benchmarks by 300%), • 90% increase in revenue per session • 10.8% boost in subscription opt-ins What fascinates me most about 1906's approach is how they turned compliance from a constraint into a competitive advantage. Instead of fighting the limitations, they engineered around them, creating scalable systems that actually enhanced their ability to educate and convert. As Peter Barsoom, their CEO, put it: "Our partnership with FERMÀT demonstrates how innovation and compliance can coexist, allowing us to stay true to our mission of transforming wellness through functional cannabis." This is a masterclass in systematic growth engineering - proving that with the right infrastructure, regulatory constraints don't have to limit innovation.

Having closely been involved in drone regulation in India for over a decade, I’ve seen how policy has slowly evolved from a highly restrictive regime to the more enabling Drone Rules, 2021. That framework gave the industry breathing space: exemptions for R&D, model drones, and prototypes helped start-ups experiment and innovate. Now comes the draft Civil Drone (Promotion and Regulation) Bill, 2025. For the first time, drones are likely to be governed by a dedicated statute with provisions on liability, enforcement, and insurance. But it also seems set to replace the framework that has guided the industry for the past four years - with little warning, and without a clear explanation for why a complete reset is needed. A few things that standout are: Excessive criminalization: Several violations are now cognisable offences, with powers to seize on suspicion. This isn’t just about compliance costs, it creates fear and uncertainty for legitimate operators  Delegated legislation: Almost every operational detail is left to future rules, leaving businesses unable to plan with confidence.  Absence of research carve-outs: Exemptions for R&D, prototypes, or model drones that supported innovation under the 2021 Rules are missing.   Type certification as a core requirement: No drone can be manufactured, sold, transferred, or operated without DGCA-issued type certification. The earlier exceptions are absent, leaving it to future rules to clarify whether any flexibility will remain. The objective of drone regulation seems to be changing – from enabling growth to likely prioritising control. The Bill promises legitimacy and accountability, but risks slowing innovation and replacing opportunity with anxiety for start-ups and operators. #drones #UAV #techpolicy Aman Taneja Nehaa Chaudhari Rutuja Pol

What qualifies as “physical work” just became the IRS’s favorite question. If you’re a developer, EPC, or tax equity investor, the new rules in IRS Notice 2025-42 will impact how you plan, document, and finance your solar projects. In this article for The Solar Standard, I break down: • What changed in the ITC eligibility rules • Why the 5% Safe Harbor is no longer enough • What counts as Physical Work (and what doesn’t) • Key risks, compliance challenges, and checklists to stay ahead Clarity, not just kilowatts, is what the market needs right now. #SolarEnergy #IRS #ITC #ProjectFinance #CleanEnergyPolicy #REPlus2025 #RenewableEnergy #TaxEquity #SolarDevelopment #TheSolarStandard

🇺🇸 🛠 Navigating the Regulatory Pathway: Steps for US LNG Projects Approval ➡️ 1. FERC Pre-filing: The journey begins with pre-filing procedures at the Federal Energy Regulatory Commission (FERC) a minimum of 6 months before formally filing. ➡️ 2. Submission of Materials: Following pre-filing, applicants must compile and submit comprehensive materials to FERC, the Pipeline and Hazardous Materials Safety Administration (PHMSA), and coordinating agencies. This step involves detailed documentation of project plans, environmental assessments, safety protocols, and impact analyses. ➡️ 3. Letter of Determination from PHMSA: PHMSA plays a crucial role in evaluating the safety aspects of LNG projects. A letter of determination from PHMSA signifies compliance with federal safety standards, confirming the project's readiness to proceed to the next phase. ➡️ 4. Final NEPA Document: The National Environmental Policy Act (NEPA) requires the preparation of an Environmental Impact Statement (EIS) or Environmental Assessment (EA) for LNG projects. The final NEPA document assesses the environmental effects of the proposed project and outlines mitigation measures to minimize adverse impacts. ➡️ 5. FERC Final Order: Upon completion of the NEPA process, FERC issues a final order, which serves as the regulatory authorization for the project. This order outlines the terms and conditions under which the project can proceed, incorporating environmental considerations and stakeholder feedback. ➡️ 6. Joint Record of Decision: The Joint Record of Decision (ROD) represents a formal agreement among regulatory agencies regarding the approval of the LNG project. It consolidates the findings of various agencies involved in the review process, providing a comprehensive basis for project approval. ➡️ 7. Authorization to Start Construction: With regulatory approvals in place, developers receive authorization to commence construction activities. This milestone marks the transition from planning to implementation, signaling the beginning of physical development. ➡️ 8. Non-FTA Approval: For LNG exports to countries without Free Trade Agreements (FTA) with the US, developers must obtain non-FTA approval from the Department of Energy (DOE). This step ensures compliance with statutory requirements governing LNG exports. ➡️ 9. Final Investment Decision (FID): The FID represents the formal commitment of financial resources to proceed with the project. It is a significant milestone indicating confidence in project viability and market demand. ➡️ 10. Construction Begins: With all regulatory and financial prerequisites met, construction activities commence, marking the culmination of the approval process and the beginning of project realization. Source Center for LNG https://lnkd.in/gyViJ93F #LNG #USLNG #FERC #DOE #FID #PHMSA

If customs walks in today, are you ready? Most aren’t and the penalties prove it. What triggers a customs audit ? 1. Random Selection Part of risk-based targeting systems to keep audits fair.  2. Red Flags Errors or inconsistencies in import declarations can raise alarms.  3. Industry Targeting   Customs focuses on industries with high fraud risks like electronics and pharma.  4. Prior Non-Compliance Past penalties or lack of response can trigger scrutiny.  5. **Related Party Transactions**   Intra-company deals face extra checks for pricing issues.  6. FTA Claims   Large claims for Free Trade Agreements may lead to reviews.  Common Mistakes That Trigger Penalties  - Misclassification  Customs uses data analytics to find errors. This can lead to a duty shortfall of up to three times.  - Undervaluation Transfer pricing reports can expose undervalued goods, resulting in fines and interest.  - FTA Misuse  Lack of origin support during claims can mean repayment of duties plus penalties.  - Poor Recordkeeping Random audits can catch missing documents, leading to fines.  - Misdeclared Dual-use Goods   These can lead to serious legal issues.  - Inconsistent Broker Instructions   Discrepancies can cause loss of benefits.  Preparation Best Practices - Assemble a Compliance Task Force    Include Trade Compliance, Finance, Logistics, and Legal teams.  - Review Historical Import Data Analyze reports from brokers and customs tools for the last 12 to 36 months.  - Validate HS Classifications  Cross-check with product specs and rulings.  - Review Valuation Methodology   Ensure all dutiable elements are included in declared values.  - Confirm Origin Documentation  Match each FTA claim with valid supplier declarations.  - Check Recordkeeping Protocol   Keep all documents accessible.  - Audit FTA Claims  Randomly select entries to trace back to source.  - Examine Related Party Transactions  Ensure customs values are based on fair market pricing.  - Spot Audit Broker Instructions  Pull recent declarations to check accuracy.  - Prepare a Compliance Report   Summarize risks and actions taken.  **Do's**  ✅ Designate a single point of contact for customs.   ✅ Be transparent but only provide requested information.   ✅ Keep an audit log of all communications.   ✅ Prepare an intro presentation outlining import processes.   ✅ Provide documents promptly and in order.  **Don'ts**  ❌ Don’t argue or blame other departments.   ❌ Don’t offer unsolicited documents.   ❌ Don’t allow unscheduled interviews with untrained staff.   ❌ Don’t say “we’ve always done it that way.”  **Post-Audit Actions**  Review findings with your broker or legal team.   Respond within the deadline to correct inaccuracies.   Implement corrective actions and document them.   Schedule a follow-up audit within six months.   Update SOPs and training based on findings.  

The Financial Action Task Force (#FATF) has released its latest June 2025 report on Complex Proliferation Financing (PF) and #Sanctions Evasion Schemes, offering a sobering reality check for compliance leaders. The findings reveal how actors exploiting global financial systems are increasingly relying on layered corporate structures, third-country brokers, and decentralized technologies to circumvent both UN and autonomous sanctions regimes. Sanctions Evasion The report identifies that the architecture of PF-related evasion is becoming more sophisticated and adaptive. Shell companies, front companies, and opaque supply chain actors—many domiciled in jurisdictions with limited beneficial ownership transparency—continue to obscure the origin, control, and end-use of sensitive goods and dual-use technologies. One alarming trend is the misuse of legitimate commercial trade corridors and third-party logistics providers to mask procurement for sanctioned regimes. These actors often rely on indirect procurement chains, deliberately fragmenting shipments and documentation across multiple intermediaries. As a result, compliance functions can no longer rely on traditional binary screening tools; the sophistication of these schemes demands a more layered and intelligence-driven approach. Digital Disruption and Legal Loopholes The FATF report outlines several typologies that challenge traditional compliance frameworks: • Use of digital assets and anonymizing technologies: Virtual assets are increasingly being used to move value discreetly across borders. Obfuscation techniques such as mixers, privacy coins, and layered wallets hinder traceability, raising the bar for effective blockchain analytics and virtual asset service provider (VASP) due diligence. • Misuse of trade finance instruments: Letters of credit, dual-use goods invoices, and shipping documentation are manipulated to disguise end-users or ultimate consignees. The complexity of documentation trails often deters scrutiny from frontline teams under time pressure. • Multi-jurisdictional structures: Corporate veils remain a persistent challenge. Risk signals such as frequent changes in ownership, unexplained cross-border payments, and intermediary involvement in high-risk goods must now be core to every enhanced due diligence review. #ProliferationFinancing #TradeBasedMoneyLaundering The FATF emphasizes that the ability of financial institutions to detect and disrupt PF activities remains uneven. Suspicious Activity Reports (SARs) and Sanctions Screening remain underutilized tools—often limited by insufficient internal escalation and an overreliance on keyword-based monitoring. Compliance leaders must therefore reassess whether internal escalation protocols, VASP onboarding, and third-party risk assessments are robust enough to detect circumvention of #exportcontrols #financialcrime