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Navigating GCP and GDPR in Vendor Selection: Key Responsibilities for Sponsors

This article draws on insights shared during a recent expert-led webinar featuring Rivka Zaibel, President and Founder of ADRES, and Diana Andrade, Founder & Managing Director of RD Privacy. Their combined expertise in GCP compliance and GDPR regulation provides a solid foundation for the following guidance on how sponsors can effectively navigate their responsibilities when […]

Source Data Verification: A Case Study in Practical DI Challenges

Data integrity (DI) efforts culminate in source data verification, a process essential for ensuring the accuracy and reliability of your data. This step safeguards your submissions, maintains operational quality, and prevents critical errors. In this final article of our four-part series, we’ll explore a case study from an R&D lab and dive into the strategies […]

Building a Data Integrity Culture in Your Startup

In July 2023, the FDA issued a warning letter to Intas Pharmaceuticals Limited, citing critical data integrity lapses. These included aborted chromatographic sequences, inadequate oversight of CGMP documents, and insufficient controls over computerized systems. The FDA found instances where laboratory staff aborted chromatographic runs without investigation, raising concerns about the reliability of analytical data. These […]

Unlocking the Mystery of 21 CFR Part 11 Compliance

One of the most common challenges for startups is navigating the labyrinth of regulatory requirements—particularly when it comes to computerized systems validation (CSV). Take, for example, a biotech company that invested in a lab system advertised as “21 CFR Part 11-compatible.” They rested assured, believing that the vendor’s certification guaranteed compliance. However, they later discovered […]

Data Integrity in Pharmaceutical Development – The Pillar of Trust

In pharmaceutical startups, expertise often centers on the science and innovation needed to bring products to life, leaving peripheral but critical activities—like data integrity (DI)—underprioritized. While DI is widely acknowledged as essential, many founders and teams struggle to understand the expectations and tools available to meet them. Let’s break down why DI matters, its core […]

The Crucial Role of Strict Adherence to aseptic processing in Pharmaceutical Manufacturing

In the highly regulated pharmaceutical and biotech industries, the quality and safety of products are paramount. Particularly in the production of injectable drugs, strict adherence to aseptic operations is not just best practice—it’s a necessity. Operators in these facilities are tasked with the vital role of ensuring that every phase of the manufacturing process is […]

Biosimilars: Regulatory, Quality, and Manufacturing Excellence

At ADRES, we specialize quality assurance in healthcare and guiding companies through the intricate journey of biosimilar development. Our expertise in Regulatory Affairs (RA), Quality Assurance (QA), and Chemistry, Manufacturing, and Controls (CMC) positions us uniquely to support biosimilar projects. Regulatory Affairs: Navigating the complex regulatory landscape is crucial for biosimilar development success. We provide strategic […]

Unlocking Biotech Valuation: Orphan Drug Impact & Regulatory Compliance

By: Lital Israeli Yagev Nurexone has recently been granted Orphan Drug Designation by the FDA for their groundbreaking treatment in Spinal Cord Injury (SCI) and is now seeking the same designation in the European Union. Why does this matter? Orphan Drug Designation is more than just a regulatory affairs consulting milestone. It’s a gateway to valuable […]

ניווט במבוך הרגולטורי: מדוע סטארט-אפים ביוטכנולוגיים בוחרים במומחיות חיצונית

בתעשיית הביוטק המתפתחת במהירות, חברות סטרטאפ ניצבות בפני אתגרים רבים, החל מהמורכבות של פיתוח מוצרים ועד לניווט במבוך של דרישות רגולטוריות. בכל הקשור לאתגר הרגולטורי, הדרך סלולה בצמתים, מכשולים והתלבטויות. וכל מפנה מוטעה יכול להוביל לעיכובים משמעותיים בלוחות הזמנים והוצאת תקציבים גדולים יותר מהמתוכנן. בלא מעט מקרים, ייעוץ רגולטורי לא רק יכול לסלול את הדרך […]

Regulatory Consultation for Global Biotech Expansion

Expanding your biotech venture globally is an exciting journey. However, it comes with its own set of challenges, especially when it comes to navigating international regulations. This is where regulatory consultation becomes crucial. Let’s explore how it can facilitate your global expansion. Navigating International Biotech Regulations Each country has its own regulatory landscape, making international […]

𝐇𝐨𝐰 𝐭𝐡𝐞 𝐅𝐃𝐀’𝐬 𝐍𝐞𝐰 𝐂𝐨𝐦𝐦𝐮𝐧𝐢𝐜𝐚𝐭𝐢𝐨𝐧 𝐌𝐞𝐚𝐬𝐮𝐫𝐞𝐬 𝐂𝐚𝐧 𝐅𝐚𝐬𝐭-𝐓𝐫𝐚𝐜𝐤 𝐁𝐢𝐨𝐩𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭 – (Biopharma Regulatory Consulting)

Authored by Lital Israeli Yagev The Food and Drug Administration (FDA) has always been pivotal in drug and biopharmaceutical development. With the enactment of the Prescription Drug User Fee Act (PDUFA) VII for the period 2023-2027, the FDA has introduced innovative measures that promise to revolutionize the way biopharmaceutical developers communicate with the agency, potentially […]

What about the Third Stage? Continuous Process Validation (CPV)

Authored by Or Degany In the intricate world of pharmaceutical and biopharmaceutical manufacturing, pharma regulatory consultants emphasize the importance of ensuring consistent quality and regulatory affairs consulting. Continuous Process Validation (CPV) is a critical player in this arena, often recognized as the third stage in the process validation lifecycle. CPV’s primary aim is to demonstrate […]

Unraveling the Intricacies of PRIME: Your Pathway to Accelerated Medicine Approval (Biotech Regulatory Affairs)

Authored by Dr. Liron Gibbs-Bar Embarking on the regulatory affairs journey of bringing a new medicinal product to the market is no small feat. The road is long and filled with regulatory hurdles, especially when aiming to meet the high standards required for regulatory approval and market access. However, there’s a beacon of hope for […]

Phase-appropriate validation – Biotech Regulatory Affairs

By Inbal Apel Are you a biotech or biopharma company embarking on the challenging journey of clinical trials? The road ahead, particularly in the early stages, is often fraught with complexities and uncertainties. One key area that usually raises questions and concerns is validating testing methods and manufacturing processes. If thoughts about CMC regulatory affairs […]

Implementing the New GCP R3 Guidelines.

Authored by Carmel Dafna The updated ICH E6 R3 introduces key improvements from Version 2. Here are fundamental changes, focusing on how they directly impact the sponsor role: Increased focus on Sponsor Oversight:The update focuses on the responsibility of the sponsors to have a greater level of oversight. ICH E6 Version 3 emphasizes a more robust […]

𝐀𝐫𝐞 𝐲𝐨𝐮 𝐬𝐭𝐫𝐮𝐠𝐠𝐥𝐢𝐧𝐠 𝐰𝐢𝐭𝐡 𝐭𝐡𝐞 𝐜𝐨𝐦𝐩𝐥𝐞𝐱 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧𝐬 𝐬𝐞𝐭 𝐛𝐲 𝐭𝐡𝐞 𝐅𝐃𝐀 𝐚𝐧𝐝 𝐄𝐌𝐀?

ADRES Webinar on Pre-Approval Inspection Readiness 𝐓𝐡𝐢𝐬 𝐰𝐞𝐛𝐢𝐧𝐚𝐫 𝐟𝐨𝐜𝐮𝐬 𝐨𝐧 𝐢𝐧𝐬𝐩𝐞𝐜𝐭𝐢𝐨𝐧 𝐫𝐞𝐚𝐝𝐢𝐧𝐞𝐬𝐬, providing comprehensive insights into the necessary activities and best practices to face regulatory inspections confidently. This webinar caters explicitly to companies involved in the clinical development of Pharmaceuticals, biologics, and combination products. We promise to demystify the process and equip you with actionable […]

Empowering Pharmaceutical and Biotech Industries through Regulatory Consulting Services

The pharmaceutical and biotech industries operate in a highly regulated environment, where compliance with stringent regulatory requirements is essential. To navigate this complex landscape successfully, companies often turn to Regulatory and development consulting services. ADRES, a reputable consulting firm, specializes in providing comprehensive solutions tailored to the unique needs of the pharmaceutical and biotech industry. […]

Let’s explore the regulatory and analytical aspects of comparing biological products.

Watch our Joint Webinar with Protagene on “Regulatory Aspects of Comparability Exercise,” ADRES is a leading international consulting and execution firm dedicated to regulatory affairs, QA, Medical QA, and CMC. We provide a comprehensive resource hub for professionals seeking information, services, and training in regulatory affairs. With a focus on regulatory compliance, guidelines, and strategies, […]

Empowering Rare Disease Treatment Development

The Financial Incentives of Orphan Drug Designation and Expert Regulatory Consulting Support Companies developing treatments for rare diseases can actually gain valuable financial incentives from an ‘orphan drug designation.’ Such a designation not only provides partial tax credit for clinical trial expenditures and waived user fees (e.g. for scientific advice) – but also eligibility for […]

Tangential Flow Filtration Technology

We want to extend a huge thank you to Or Degany from ADRES Int’l Biotech Consultation & Execution and Alessandra Giordano and Eran Gertman from Pall – Biotech for hosting a fantastic webinar on Tangential Flow Filtration Technology. For those who were unable to attend, the recording is available here: Their expertise in the field […]

The end of animal testing in America?

Not so fast…President Biden created a buzz when he signed a law, eliminating the requirement to test a drug or medical device on animals before testing their effectiveness and safety in humans. But the road is still long and winding, as non-animal technologies still need to be proven as an effective tool for evaluating both […]

GMP Annex 1 – Final Revision

𝐓𝐡𝐞 𝐄𝐮𝐫𝐨𝐩𝐞𝐚𝐧 𝐔𝐧𝐢𝐨𝐧 𝐫𝐞𝐜𝐞𝐧𝐭𝐥𝐲 𝐢𝐬𝐬𝐮𝐞𝐝 𝐭𝐡𝐞 𝐟𝐢𝐧𝐚𝐥 𝐫𝐞𝐯𝐢𝐬𝐢𝐨𝐧 𝐨𝐟 𝐆𝐌𝐏 𝐀𝐧𝐧𝐞𝐱 1: 𝐌𝐚𝐧𝐮𝐟𝐚𝐜𝐭𝐮𝐫𝐞 𝐨𝐟 𝐒𝐭𝐞𝐫𝐢𝐥𝐞 𝐌𝐞𝐝𝐢𝐜𝐢𝐧𝐚𝐥 𝐏𝐫𝐨𝐝𝐮𝐜𝐭𝐬, 𝐕𝐨𝐥. 4 𝐟𝐨𝐫 2022. Many of the changes are more stringent than in previous versions. For example: • Separate change rooms are required for entering and leaving production areas if the Contamination Control Strategy (CCS) indicates the risk of contamination is high • For cleanroom qualification and EM, all grades are required to measure the total particles equal to or […]

Attention startups in the bio pharma community!

Last week at Adres we hosted our first LinkedIn Live with over 200 participants It was great to share our knowledge and experience with the bio pharma community and give you the confidence that you are on the right track with your clinical development program. In this session, we focused on: Process Validation and the importance of […]

Apply for SME status today!

ADRES EU, the European subsidiary of ADRES, can provide your company with valuable scientific and regulatory assistance through a simple, quick, and inexpensive process! Between 2016-2020: The European Medicines Agency (EMA) offers different incentives for micro, Small and Medium-sized Enterprises (SMEs). SMEs are eligible for consideration in EU expedite-development programs, as well as to receive […]

FDA’s New Advanced Therapies “Super Office” to Benefit Medical Startups – Biotech Regulatory Solutions.

In mid-September, the US Food and Drug Administration (FDA) announced that the Office of Tissues and Advanced Therapies (OTAT) will become the Office of Therapeutic Products (OTP). The organizational changes, which were approved in August and went into effect on September 16, are far more than just a name change. In this era of rapid advancement, […]

Source Data Verification: A Case Study in Practical DI Challenges

Data integrity (DI) efforts culminate in source data verification, a process essential for ensuring the accuracy and reliability of your data. This step safeguards your submissions, maintains operational quality, and prevents critical errors. In this final article of our four-part series, we’ll explore a case study from an R&D lab and dive into the strategies […]

Building a Data Integrity Culture in Your Startup

In July 2023, the FDA issued a warning letter to Intas Pharmaceuticals Limited, citing critical data integrity lapses. These included aborted chromatographic sequences, inadequate oversight of CGMP documents, and insufficient controls over computerized systems. The FDA found instances where laboratory staff aborted chromatographic runs without investigation, raising concerns about the reliability of analytical data. These […]

Unlocking the Mystery of 21 CFR Part 11 Compliance

One of the most common challenges for startups is navigating the labyrinth of regulatory requirements—particularly when it comes to computerized systems validation (CSV). Take, for example, a biotech company that invested in a lab system advertised as “21 CFR Part 11-compatible.” They rested assured, believing that the vendor’s certification guaranteed compliance. However, they later discovered […]

Data Integrity in Pharmaceutical Development – The Pillar of Trust

In pharmaceutical startups, expertise often centers on the science and innovation needed to bring products to life, leaving peripheral but critical activities—like data integrity (DI)—underprioritized. While DI is widely acknowledged as essential, many founders and teams struggle to understand the expectations and tools available to meet them. Let’s break down why DI matters, its core […]

The Crucial Role of Strict Adherence to aseptic processing in Pharmaceutical Manufacturing

In the highly regulated pharmaceutical and biotech industries, the quality and safety of products are paramount. Particularly in the production of injectable drugs, strict adherence to aseptic operations is not just best practice—it’s a necessity. Operators in these facilities are tasked with the vital role of ensuring that every phase of the manufacturing process is […]

Biosimilars: Regulatory, Quality, and Manufacturing Excellence

At ADRES, we specialize quality assurance in healthcare and guiding companies through the intricate journey of biosimilar development. Our expertise in Regulatory Affairs (RA), Quality Assurance (QA), and Chemistry, Manufacturing, and Controls (CMC) positions us uniquely to support biosimilar projects. Regulatory Affairs: Navigating the complex regulatory landscape is crucial for biosimilar development success. We provide strategic […]

Unlocking Biotech Valuation: Orphan Drug Impact & Regulatory Compliance

By: Lital Israeli Yagev Nurexone has recently been granted Orphan Drug Designation by the FDA for their groundbreaking treatment in Spinal Cord Injury (SCI) and is now seeking the same designation in the European Union. Why does this matter? Orphan Drug Designation is more than just a regulatory affairs consulting milestone. It’s a gateway to valuable […]

ניווט במבוך הרגולטורי: מדוע סטארט-אפים ביוטכנולוגיים בוחרים במומחיות חיצונית

בתעשיית הביוטק המתפתחת במהירות, חברות סטרטאפ ניצבות בפני אתגרים רבים, החל מהמורכבות של פיתוח מוצרים ועד לניווט במבוך של דרישות רגולטוריות. בכל הקשור לאתגר הרגולטורי, הדרך סלולה בצמתים, מכשולים והתלבטויות. וכל מפנה מוטעה יכול להוביל לעיכובים משמעותיים בלוחות הזמנים והוצאת תקציבים גדולים יותר מהמתוכנן. בלא מעט מקרים, ייעוץ רגולטורי לא רק יכול לסלול את הדרך […]

Regulatory Consultation for Global Biotech Expansion

Expanding your biotech venture globally is an exciting journey. However, it comes with its own set of challenges, especially when it comes to navigating international regulations. This is where regulatory consultation becomes crucial. Let’s explore how it can facilitate your global expansion. Navigating International Biotech Regulations Each country has its own regulatory landscape, making international […]

𝐇𝐨𝐰 𝐭𝐡𝐞 𝐅𝐃𝐀’𝐬 𝐍𝐞𝐰 𝐂𝐨𝐦𝐦𝐮𝐧𝐢𝐜𝐚𝐭𝐢𝐨𝐧 𝐌𝐞𝐚𝐬𝐮𝐫𝐞𝐬 𝐂𝐚𝐧 𝐅𝐚𝐬𝐭-𝐓𝐫𝐚𝐜𝐤 𝐁𝐢𝐨𝐩𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭 – (Biopharma Regulatory Consulting)

Authored by Lital Israeli Yagev The Food and Drug Administration (FDA) has always been pivotal in drug and biopharmaceutical development. With the enactment of the Prescription Drug User Fee Act (PDUFA) VII for the period 2023-2027, the FDA has introduced innovative measures that promise to revolutionize the way biopharmaceutical developers communicate with the agency, potentially […]

What about the Third Stage? Continuous Process Validation (CPV)

Authored by Or Degany In the intricate world of pharmaceutical and biopharmaceutical manufacturing, pharma regulatory consultants emphasize the importance of ensuring consistent quality and regulatory affairs consulting. Continuous Process Validation (CPV) is a critical player in this arena, often recognized as the third stage in the process validation lifecycle. CPV’s primary aim is to demonstrate […]

Unraveling the Intricacies of PRIME: Your Pathway to Accelerated Medicine Approval (Biotech Regulatory Affairs)

Authored by Dr. Liron Gibbs-Bar Embarking on the regulatory affairs journey of bringing a new medicinal product to the market is no small feat. The road is long and filled with regulatory hurdles, especially when aiming to meet the high standards required for regulatory approval and market access. However, there’s a beacon of hope for […]

Phase-appropriate validation – Biotech Regulatory Affairs

By Inbal Apel Are you a biotech or biopharma company embarking on the challenging journey of clinical trials? The road ahead, particularly in the early stages, is often fraught with complexities and uncertainties. One key area that usually raises questions and concerns is validating testing methods and manufacturing processes. If thoughts about CMC regulatory affairs […]

Implementing the New GCP R3 Guidelines.

Authored by Carmel Dafna The updated ICH E6 R3 introduces key improvements from Version 2. Here are fundamental changes, focusing on how they directly impact the sponsor role: Increased focus on Sponsor Oversight:The update focuses on the responsibility of the sponsors to have a greater level of oversight. ICH E6 Version 3 emphasizes a more robust […]

𝐀𝐫𝐞 𝐲𝐨𝐮 𝐬𝐭𝐫𝐮𝐠𝐠𝐥𝐢𝐧𝐠 𝐰𝐢𝐭𝐡 𝐭𝐡𝐞 𝐜𝐨𝐦𝐩𝐥𝐞𝐱 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧𝐬 𝐬𝐞𝐭 𝐛𝐲 𝐭𝐡𝐞 𝐅𝐃𝐀 𝐚𝐧𝐝 𝐄𝐌𝐀?

ADRES Webinar on Pre-Approval Inspection Readiness 𝐓𝐡𝐢𝐬 𝐰𝐞𝐛𝐢𝐧𝐚𝐫 𝐟𝐨𝐜𝐮𝐬 𝐨𝐧 𝐢𝐧𝐬𝐩𝐞𝐜𝐭𝐢𝐨𝐧 𝐫𝐞𝐚𝐝𝐢𝐧𝐞𝐬𝐬, providing comprehensive insights into the necessary activities and best practices to face regulatory inspections confidently. This webinar caters explicitly to companies involved in the clinical development of Pharmaceuticals, biologics, and combination products. We promise to demystify the process and equip you with actionable […]

Empowering Pharmaceutical and Biotech Industries through Regulatory Consulting Services

The pharmaceutical and biotech industries operate in a highly regulated environment, where compliance with stringent regulatory requirements is essential. To navigate this complex landscape successfully, companies often turn to Regulatory and development consulting services. ADRES, a reputable consulting firm, specializes in providing comprehensive solutions tailored to the unique needs of the pharmaceutical and biotech industry. […]

Let’s explore the regulatory and analytical aspects of comparing biological products.

Watch our Joint Webinar with Protagene on “Regulatory Aspects of Comparability Exercise,” ADRES is a leading international consulting and execution firm dedicated to regulatory affairs, QA, Medical QA, and CMC. We provide a comprehensive resource hub for professionals seeking information, services, and training in regulatory affairs. With a focus on regulatory compliance, guidelines, and strategies, […]

Empowering Rare Disease Treatment Development

The Financial Incentives of Orphan Drug Designation and Expert Regulatory Consulting Support Companies developing treatments for rare diseases can actually gain valuable financial incentives from an ‘orphan drug designation.’ Such a designation not only provides partial tax credit for clinical trial expenditures and waived user fees (e.g. for scientific advice) – but also eligibility for […]

Tangential Flow Filtration Technology

We want to extend a huge thank you to Or Degany from ADRES Int’l Biotech Consultation & Execution and Alessandra Giordano and Eran Gertman from Pall – Biotech for hosting a fantastic webinar on Tangential Flow Filtration Technology. For those who were unable to attend, the recording is available here: Their expertise in the field […]

The end of animal testing in America?

Not so fast…President Biden created a buzz when he signed a law, eliminating the requirement to test a drug or medical device on animals before testing their effectiveness and safety in humans. But the road is still long and winding, as non-animal technologies still need to be proven as an effective tool for evaluating both […]

GMP Annex 1 – Final Revision

𝐓𝐡𝐞 𝐄𝐮𝐫𝐨𝐩𝐞𝐚𝐧 𝐔𝐧𝐢𝐨𝐧 𝐫𝐞𝐜𝐞𝐧𝐭𝐥𝐲 𝐢𝐬𝐬𝐮𝐞𝐝 𝐭𝐡𝐞 𝐟𝐢𝐧𝐚𝐥 𝐫𝐞𝐯𝐢𝐬𝐢𝐨𝐧 𝐨𝐟 𝐆𝐌𝐏 𝐀𝐧𝐧𝐞𝐱 1: 𝐌𝐚𝐧𝐮𝐟𝐚𝐜𝐭𝐮𝐫𝐞 𝐨𝐟 𝐒𝐭𝐞𝐫𝐢𝐥𝐞 𝐌𝐞𝐝𝐢𝐜𝐢𝐧𝐚𝐥 𝐏𝐫𝐨𝐝𝐮𝐜𝐭𝐬, 𝐕𝐨𝐥. 4 𝐟𝐨𝐫 2022. Many of the changes are more stringent than in previous versions. For example: • Separate change rooms are required for entering and leaving production areas if the Contamination Control Strategy (CCS) indicates the risk of contamination is high • For cleanroom qualification and EM, all grades are required to measure the total particles equal to or […]

Attention startups in the bio pharma community!

Last week at Adres we hosted our first LinkedIn Live with over 200 participants It was great to share our knowledge and experience with the bio pharma community and give you the confidence that you are on the right track with your clinical development program. In this session, we focused on: Process Validation and the importance of […]

Apply for SME status today!

ADRES EU, the European subsidiary of ADRES, can provide your company with valuable scientific and regulatory assistance through a simple, quick, and inexpensive process! Between 2016-2020: The European Medicines Agency (EMA) offers different incentives for micro, Small and Medium-sized Enterprises (SMEs). SMEs are eligible for consideration in EU expedite-development programs, as well as to receive […]

FDA’s New Advanced Therapies “Super Office” to Benefit Medical Startups – Biotech Regulatory Solutions.

In mid-September, the US Food and Drug Administration (FDA) announced that the Office of Tissues and Advanced Therapies (OTAT) will become the Office of Therapeutic Products (OTP). The organizational changes, which were approved in August and went into effect on September 16, are far more than just a name change. In this era of rapid advancement, […]

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