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

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 compliance. 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 that a commercial pharmaceutical and biopharmaceutical manufacturing process remains in a state of control post-approval.

Understanding CPV Implementation Challenges

Implementing a CPV program, especially for legacy biopharmaceutical products with a long manufacturing history, poses significant challenges. These products, which have been licensed and manufactured over extended periods, may not initially align with contemporary CPV methodologies. Their process designs may be less rigorous, control strategies less developed, and process parameter classifications not fully accomplished. This gap between older manufacturing processes and current regulatory expectations requires careful navigation.

ADRES: Your Partner in CPV Implementation

At ADRES, we understand the intricacies of implementing CPV in the biopharmaceutical sector. Implementing CPV can be daunting, especially when dealing with legacy products. Understanding the nuances of process control, regulatory compliance, and quality assurance within the CPV framework requires expertise and experience. 

If you’re navigating these complex waters, reaching out for expert assistance can make a significant difference.

Whether you are just beginning to explore the world of CPV or want to enhance your existing program, our team at ADRES is here to offer guidance and support. We are committed to helping you understand and implement CPV effectively, ensuring your pharmaceutical and biopharmaceutical manufacturing processes meet the highest quality and control standards.

If you have any questions or need further assistance, please feel free to reach out to us at https://adres.bio/contact-us.

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 applicants, particularly those in the academic sector and small to medium-sized enterprises (SMEs): the PRIME scheme by the European Medicines Agency (EMA).

Launched in 2016, the PRIority MEdicines (PRIME) scheme represents a pivotal shift in the EMA’s approach to medicinal regulation. Its primary goal is straightforward yet ambitious: to offer continuous scientific and regulatory guidance, coupled with an accelerated assessment process for new medicines that target unmet medical needs and hold significant public interest.

For researchers and companies working on groundbreaking treatments, PRIME offers a unique opportunity. Early Entry PRIME status can be a game-changer, especially for SMEs and academic applicants. This status is granted when proof of principle is demonstrated, opening doors to invaluable guidance from regulators early in the development process.

The EMA’s recent revision to the PRIME guidelines introduces several key features to enhance the scheme’s effectiveness:

  1. Pre-submission meetings to assist applicants in planning their PRIME application.
  2. Expedited follow-up scientific advice with shortened timelines, providing quicker access to essential guidance.
  3. A submission readiness meeting about a year before the marketing authorization application (MAA) filing date, offering a platform to discuss the development status and readiness of the marketing application dossier.
  4. A revamped approach involving the submission and maintenance of a regulatory roadmap and product development tracker, taking the place of the PRIME annual update.

These enhancements are designed to deepen knowledge, and support accelerated assessments, significantly benefiting those navigating the complex waters of medicinal product development.

At ADRES, we understand the intricacies of the regulatory landscape, including the PRIME designation. Our team has extensive regulatory submissions experience, catering to SME and non-SME companies. 

We recognize the challenges and opportunities of seeking PRIME status and are equipped to guide you every step of the way.

Navigating the PRIME pathway can be daunting, but with proper support and guidance, it’s a journey you can embark on with confidence. 

You’ve got this!

If you have any questions or need further assistance, please feel free to reach out to us at https://adres.bio/contact-us.

Phase-appropriate validation – Biotech Regulatory Affairsย 

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 keep you up at night, you’re not alone.

In the nascent phases of clinical trials, it’s typical for manufacturing methods and processes to be in a state of evolution. They are often still being refined, adjusted, and understood. This fluidity can make full validation not just challenging but sometimes unnecessary and even counterproductive. This is especially true for companies taking their first steps in clinical research and development.

To provide some perspective, let’s consider the guidelines laid out by the European Medicines Agency (EMA). Specifically, their guideline on “strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products.” This guideline offers a critical insight: it points out that “the methods used for determination of the strength and/or the potency of the product need to be relevant for the intended mechanism of action, reliable, and qualified.” Note the emphasis on being ‘qualified’ rather than ‘validated.’ This distinction is crucial and underscores a more tailored approach to validation that is phase-appropriate.

Understanding the nuances of these requirements is vital for navigating the regulatory landscape successfully. It’s not just about ticking boxes; it’s about ensuring that your methods are robust, reliable, and appropriate for the stage of development your product is in. This phase-appropriate validation approach allows for a more flexible, adaptive, and ultimately more effective and cheap pathway through the early stages of clinical development.

But how do you translate these guidelines into actionable steps? How do you plan and align your company’s Gantt chart for each stage of clinical development? The task can seem daunting, especially when juggling the myriad other responsibilities that come with running a biotech or biopharma company.

This is where expert guidance on regulatory affairs can make a world of difference. Seeking advice from those who have navigated these waters before can provide clarity and direction. It can transform a confusing maze of regulations and best practices into a clear roadmap towards successful clinical trial progression.

regulatory affairs consulting

Adres is a regulatory affairs consultancy. For those who find themselves at this complex intersection of innovation and regulation, seeking expert guidance is not just helpful โ€“ it’s essential. Don’t hesitate to reach out for support. Remember, in this journey, you’re not alone.

Feel free to contact us and pick our minds https://adres.bio/contact-us.

๐€๐ซ๐ž ๐ฒ๐จ๐ฎ ๐ฌ๐ญ๐ซ๐ฎ๐ ๐ ๐ฅ๐ข๐ง๐  ๐ฐ๐ข๐ญ๐ก ๐ญ๐ก๐ž ๐œ๐จ๐ฆ๐ฉ๐ฅ๐ž๐ฑ ๐ซ๐ž๐ ๐ฎ๐ฅ๐š๐ญ๐ข๐จ๐ง๐ฌ ๐ฌ๐ž๐ญ ๐›๐ฒ ๐ญ๐ก๐ž ๐…๐ƒ๐€ ๐š๐ง๐ ๐„๐Œ๐€?

ADRES Webinar on Pre-Approval Inspection Readiness

๐“๐ก๐ข๐ฌ ๐ฐ๐ž๐›๐ข๐ง๐š๐ซ ๐Ÿ๐จ๐œ๐ฎ๐ฌ ๐จ๐ง ๐ข๐ง๐ฌ๐ฉ๐ž๐œ๐ญ๐ข๐จ๐ง ๐ซ๐ž๐š๐๐ข๐ง๐ž๐ฌ๐ฌ, 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 strategies to transform uncertainty into confidence.

Whether it’s understanding the implications of a Voluntary Action Indicated (VAI) status from a key subcontractor or simply refining your readiness checklist, we’ve got you covered.

If you have any questions or need further assistance, please feel free to reach out to us at https://adres.bio/contact-us.

Join our YouTube channel, where you can find our original videos, with relevant information.


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. With their expertise, ADRES empowers organizations to achieve regulatory compliance and drive innovation forward.

The Significance of Scientific and Regulatory Consulting Services:

Scientific and Regulatory consulting services have become indispensable for the pharmaceutical and biotech industries. These services encompass a wide range of expertise and support to assist companies in meeting the intricate regulatory requirements governing drug development, manufacturing, and distribution. ADRES recognizes the critical role of regulatory compliance in these sectors and offers specialized services to address the unique challenges faced by pharmaceutical and biotech companies.

Regulatory Affairs Consultants for the Pharma industry:

ADRES boasts a team of experienced pharma regulatory consultants who possess a deep understanding of the complex regulatory landscape. These experts assist organizations in navigating the regulatory pathways for drug approvals, providing guidance on compliance with regional and international regulatory standards. ADRES’ consultants stay updated with the latest regulations, ensuring clients receive accurate and timely advice to expedite the approval process while maintaining compliance.

Tailored regulatory solutions for biotech companies.

Biotech companies often face distinct regulatory challenges due to the innovative nature of their products. ADRES recognizes these challenges and provides Tailored regulatory solutions to biotech companies.These solutions encompass strategic advice on regulatory strategies for novel therapies, assistance in preparing regulatory submissions, and support in navigating regulatory hurdles unique to the biotech industry. By leveraging ADRES’ expertise, biotech companies can streamline their regulatory processes and accelerate time to market.

Compliance Audits and Remediation:

ADRES offers comprehensive compliance audits to evaluate the regulatory status of pharmaceutical and biotech companies. Through meticulous assessments, ADRES identifies potential compliance gaps and recommends remediation strategies. This proactive approach helps organizations address deficiencies before regulatory inspections, minimizing the risk of penalties and disruptions to operations.

Global Regulatory Strategy:

Navigating global regulatory requirements can be challenging for pharmaceutical and biotech companies with an international presence. ADRES assists clients in developing robust global regulatory strategies, taking into account regional variations, harmonization initiatives, and market access considerations. This ensures that organizations can streamline their regulatory processes across multiple jurisdictions, minimizing complexity and maximizing market opportunities.

Regulatory compliance is paramount for success in the pharmaceutical and biotech industries. ADRES, a leading regulatory consulting firm, offers tailored solutions to empower organizations in meeting regulatory requirements and driving innovation. With a team of expert pharma regulatory consultants and a focus on specialized biotech regulatory solutions, ADRES enables companies to navigate the complex landscape effectively. Through services such as compliance audits, global regulatory strategies, and remediation support, ADRES ensures that pharmaceutical and biotech companies can focus on their core objectives while maintaining compliance and achieving regulatory success.

If you have any questions or need further assistance, please feel free to reach out to us at https://adres.bio/contact-us.

Join our YouTube channel, where you can find our original videos, with relevant information.

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, ADRES’s regulatory affairs professionals offer valuable insights and expertise to navigate the complex Biotech landscape. From product registration to quality assurance, ADRES supports startups and companies in staying up-to-date and ensuring regulatory compliance in various life sciences industries.

We are thrilled to invite you to watch an exclusive video by ADRES on the topic of “Regulatory and Analytical Aspects of Comparability of Biological Products.” This video offers valuable insights into the intricate world of regulatory frameworks and analytical approaches in ensuring the comparability of biological products.

By watching this video, you will gain a comprehensive understanding of the challenges, best practices, and emerging trends in this critical field. The content covers regulatory requirements, analytical techniques, case studies, and future directions, providing you with the latest knowledge and industry expertise.

We believe that this video will be a valuable resource for professionals, researchers, and anyone interested in the regulatory and analytical aspects of the comparability of biological products. Don’t miss out on this opportunity to enhance your knowledge and stay up-to-date with the advancements in the field.

If you have any questions or need further assistance, please feel free to reach out to us at https://adres.bio/contact-us. We look forward to hearing your feedback and insights after watching the video.

Thank you for your attention, and we hope you will find the video informative and insightful.

We are excited to offer you an additional resource to complement the video on “Regulatory and Analytical Aspects of Comparability of Biological Products” by ADRES. In addition to the video, we have prepared a downloadable PDF file presentation summarizing the key points covered in the video.

The presentation serves as a concise and visual summary of the important concepts, regulatory frameworks, analytical approaches, and case studies discussed in the video. It offers a convenient way to revisit and reinforce your understanding of the topic at your own pace.

To download the presentation, please click on the following link.

Download file

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 โ€˜orphan drug designation.โ€™

Such a designation not only provides partial tax credit for clinical trial expenditures and waived user fees (e.g. for scientific advice) โ€“ but also eligibility for 7/10 years of marketing exclusivity in the US/EU, respectively.

Additionally, according to a recent study (- https://ojrd.biomedcentral.com/articles/10.1186/s13023-017-0665-6 LINK TO THE study), the โ€˜orphanโ€™ designation appears to be successful at generating positive value for companies, as seen by the positive and significant average increases in stock prices.

The expert regulatory consulting team at ADRES has extensive experience in obtaining orphan drug status, in both the US and EU.

We can advise and prepare such applications for a variety of technologies and indications โ€“ including for challenging circumstances in which a strong scientific rationale is required.

If you’re interested in learning more about rare diseases, including how to determine if a drug is eligible for Orphan Drug Designation, the process for submitting to OMPD, and how to justify the investment needed for drug development, then downloading the file is definitely recommended. It contains valuable information on all of these topics and more.

Download the file

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 was invaluable, providing solutions to practical challenges that are faced by biopharma users in R&D, pilot, or commercial settings. The insights shared, including related regulatory expectations, were insightful and will undoubtedly benefit many in the industry.

Thank you to the team at ADRES and Pall-Biotech for organizing and sharing their expertise with us. We look forward to attending future webinars.

Feel free to Contact us for any questions and consultations, weโ€™ll be happy to assist!

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 safety and effectiveness.
As part of the FDA efforts to support its Toxicology Working Group in advancing the goals of identifying new technologies that could potentially improve toxicity predictivity as well as to support animal 3Rs (Replacement, Reduction, and Refinement), the agency formed the Alternative Methods Working Group. This program focuses on opportunities for evolving and innovative technologies to advance useful tools for testing the effectiveness and safety of therapeutic products, such as microphysiological systems (MPS).


One example of such systems are organoids, self-organized, three-dimensional tissue cultures derived from stem cells, that can divide indefinitely and form tiny structures that resemble miniature organs composed of many cell types. Researchers have been able to produce organoids that resemble the brain, kidney, lung, intestine, stomach, and liver, with many more on the way.
Another subset class of MPS is organs-on-a-chip, which consists of a miniaturized physiological environment engineered to yield and/or analyze functional tissue units capable of modeling targeted organ-level responses.
In contrast to the US, the principle of the 3Rs has been present in spirit in EU legislation, from as early as 1986, and it was made a legal requirement in 2010 in Directive 2010/63/EU.
From our experience and correspondence with both the FDA and EMA, the latter seems much more committed to the 3Rs approach around in vivo testing. The EMA will more often accept proof of concept studies solely based on in vitro or in silico tests and may require only rodents for toxicological studies, not just for biologicals.
Letโ€™s hope the FDA will manage to commit to this advanced approach sooner than we assume ๐Ÿ˜‰
 

Feel free to Contact us for any questions and consultations, weโ€™ll be happy to assist!

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 success rate for SME marketing authorization applications for human medicines more than doubled, reaching 89% in 2020
  • More than 4 in 10 medicines selected for EMAโ€™s PRIME: priority medicines scheme were from SMEs
  • SMEs developed nearly 20% of all human medicines recommended for authorization in 2020; half of these target a rare disease.

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 regulatory, financial, and administrative assistance supporting the product development process, including:

  • Regulatory, administrative, and procedural assistance including SME briefing meetings
  • Fee reductions for scientific advicescientific services, and inspections
  • Fee exemptions for certain EMA administrative services
  • SMEs can apply for a PRIME on the basis of compelling pre-clinical data and tolerability data from initial clinical trials instead of clinically meaningful improvement of efficacy
  • Certification procedure at any time during the development of an ATMP
  • Approaching the Innovation task force, which provides a platform to open an informal dialogue with the Agency and proactively identify scientific, legal and regulatory issues arising from their developments
  • Deferral of the fee payable for an application for marketing authorization and related activities (e.g., inspections, translations of the product information)
  • Fee reductions and exemptions for post-authorization procedures and pharmacovigilance activities
  • and moreโ€ฆ

SMEs are enterprises that meet the following criteria:

  • Employ fewer than 250 persons and
  • Have an annual turnover not exceeding EUR 50 million, and/or an annual balance sheet total not exceeding EUR 43 million.

So, what do you need to do? Almost nothing!

Step 1. Write us to: tanya@adres.bio

Step 2. We will assess your organizationโ€™s eligibility for SME status

Step 3. If eligible, we will request an SME status for your organization (to be annexed to ADRES EU).

 It takes approximately one month to obtain an SME status, while no EMA fee is required.

https://www.youtube.com/watch?v=Zp-zMrzuLOs[LIY1]  This is an explanation of SME status by the EMA

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