The Henrici Group is a consultancy that provides strategic and practical guidance and support to organizations regulated by healthcare regulatory agencies, focusing on quality and compliance solutions for biopharmaceuticals.

Henrici Group

The Henrici Group is a New York-based consultancy that provides strategic and practical guidance and support to organizations regulated by the US Food and Drug Administration and healthcare regulatory agencies from around the world. The firm emphasizes quality and safety in medicines and healthcare products.

The Henrici Group

Henrici Group | 525 followers on LinkedIn. Collaborative Solutions for REAL-WORLD Quality + Compliance | Henrici Group (HG) is a boutique New York-based consulting firm that provides strategic and hands-on quality and compliance support to the pharmaceutical industry. HG collaborates with organizational leadership and personnel across multiple functional areas; developing and executing scalable quality initiatives to assure sustainable compliance with regulations, guidance, industry standards and best practices.

We are a collaborative team with expertise across the product development lifecycle, including Research &amp; Development, Clinical Research and Operations, Quality Assurance, Commercial Manufacturing, Pharmacovigilance and Regulatory Affairs; as well as extensive experience in aseptic and sterile manufacturing, solid dosage, drugs &amp; generics, biologics &amp; biosimilars, and medical devices.

CFO/COO at Henrici Group

Michael Economos

Quality Assurance Consultancy Leader | Expert Chemist | Driving Excellence in QA & Compliance in Pharma, Biotech, and Medical Devices

Melvin Colón, MEM, MSMC

VP of Computer System Validation

Oktay OLCUM

Devoted to PATIENTS, passionate about the power of DATA | Pharma & Biotech Consulting | Data Governance & Data Integrity | Founder and CEO at The…

Kir Henrici

Today, we honor the men and women who have so selflessly served our country. Your sacrifice, courage, and unwavering bravery have shaped the freedoms we cherish today. Thank you for all that you have given and continue to carry. #VeteransDay #ThankYou #Gratitude #henricigroup

‼️ Attending the PDA - Parenteral Drug Association Aseptic Processing of Biopharmaceuticals Conference in Incheon, South Korea? We are! 🗣️ Come see our CEO Kir Henrici speak at her session, Practical Data Governance: Case Studies in Enabling Data Integrity Assurance by-Design, on Wednesday October 30, 2024 at 1:45pm. 📊 This presentation describes practical Data Governance measures to enable data integrity assurance. Through real-world examples, participants will gain insight into the application of data governance principles across organizational cultures, manual processes, computerized systems, and complex, hybrid environments in support of effective risk-based data integrity control strategies. ⬇️ Click below for more info. We hope to see you there! #DataIntegrity #DataGovernance #PDA

Happy Indigenous Peoples' Day. This day encourages reflection, education, and appreciation of Indigenous traditions. Let’s come together to acknowledge the past and work towards a more inclusive future.

✨ On behalf of HG, thank you, International Pharmaceutical Academy , for a wonderful experience at the 20th Annual GMP Update BPF Mise à Jour last week in Montreal. Rebecca Tan , your energy is infectious! Huge thanks to you and the attendees for a warm welcome and a remarkable conference. What a fantastic job by our Vice President of Quality & Compliance, Meg Gallwitz . Her presentation on the Pharmaceutical Quality Management System was absolutely captivating. Thank you for sharing your passion and expertise! And last but certainly not least, a job well done by our CEO, Kir Henrici . Your presentation on "Data Integrity: From Remediation to Innovation" is an important reminder of where we are and where we want to go.. all in the name of patient safety and product quality! 🫶

🚨 Did you see that the European Commission’s Medical Device Coordination Group (MDCG) has issued new guidance to implement corrective and preventive action (CAPA) in order to address non-compliances identified during joint assessments? Check this out! ⬇️ #RegulatoryScience #MDCG #CAPA

🔎Hot news is right! Really interesting guideline for the clinical space. Well said, Ulrich Köllisch ! #FDA #clinicalinvestigations #henricigroup #dataintegrity

Check it out ⬇️🙌 #artificialintelligence

📢 Mark your calendars! Henrici Group is coming to the 20th Annual GMP Update BPF Mise à jour hosted by the International Pharmaceutical Academy in Montreal, Canada on October 2-3, 2024. Our CEO, Kir Henrici will be speaking on day 2 from 2:15-2:45PM. Come join the discussion on "Data Integrity: From Remediation to Innovation" 🔗 Learn more here: https://gmp.ipacanada.com/ #GMP #DataIntegrity #Innovation #LifeSciences #Pharmaceuticals #PatientSafety #Compliance #AI #DigitalTransformation #RiskManagement

💖 A huge THANK YOU to everyone who attended our recent “For the Love of Data” webinar, especially to our incredible guest speaker, Kurt In Albon, MSc for sharing such valuable insights on Cyber Security and the Emerging Responsibility of Quality Assurance amidst the Digital Revolution. Your expertise truly made this event special! 🫶🏽We also want to extend our appreciation to all the attendees for your engaging questions, ideas, and participation. 🎥 Missed it or want to revisit the session? No worries! A recorded copy will be shared with all attendees soon. If you experience any issues receiving your copy, please reach out to us at hg@thehenricigroup.com for assistance. 🔔 Stay tuned! We're already planning our next exciting webinar – more details to come soon! Thanks again for being a part of this vibrant data-loving community, and we look forward to seeing you at future events! #ThankYou #FortheLoveofData #Gratitude #GuestSpeaker #StayTuned #DataGovernance #Pharma #CyberSecurity #Quality

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The Henrici Group