ADRES Webinar on Pre-Approval Inspection Readiness
๐๐ก๐ข๐ฌ ๐ฐ๐๐๐ข๐ง๐๐ซ ๐๐จ๐๐ฎ๐ฌ ๐จ๐ง ๐ข๐ง๐ฌ๐ฉ๐๐๐ญ๐ข๐จ๐ง ๐ซ๐๐๐๐ข๐ง๐๐ฌ๐ฌ, 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.
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 โorphan 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 โorphanโ 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.
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, weโll be happy to assist!
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. Letโs hope the FDA will manage to commit to this advanced approach sooner than we assume ๐
Feel free to Contact us for any questions and consultations, weโll be happy to assist!
Many of the changes are more stringent than in previous versions. For example:
โข Separate change rooms are required for entering and leaving production areas if the Contamination Control Strategy (CCS) indicates the risk of contamination is high
โข For cleanroom qualification and EM, all grades are required to measure the total particles equal to or greater 0.5 and 5 ยตm/m3, with instructions to consider 5ยตm particles measurements where limits are not specified
โข For Interventions, all non-qualified interventions should be recorded in the batch record, authorized by the quality unit, and assessed.
We thought the most interesting change required the bioburden samples be taken prior to the first filter if a redundant filtration setup is used.
These are just a few of the changes to the annex. To learn how these and other updates could impact your operations, download our GMP Annex 1 guidelines and reach out.
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 arriving prepared for this critical milestone
When is the right time to start preparing?
Shifting your mindset to understand the โProcessย isย the Productโ
Avoiding delays on your critical path
If you werenโt able to join us live, you can stillย watch the recordingย here:
Feel free to Contact us for any questions and consultations, weโll be happy to assist!
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
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 advice, scientific 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 moreโฆ
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 organizationโs 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.
FDAโs New Advanced Therapies โSuper Officeโ 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.ย In this era of rapid advancement, biotech regulatory consulting plays a crucial role in navigating FDA changes.
OTP, which like OTAT is part of the FDAโs Center for Biologics Evaluation and Research (CBER), will be elevated to a Super Office. This will allow CBER to manage the program at a macro level and better position the center to address an ever-changing public health landscape. These changes are not just significant locally but will influence global regulatory services and their strategies.
The new organizational changes will improve functional alignment, increase the review capabilities of the organization, and enhance expertise on new cell and gene therapies. It will also include more full-time staff and supervisory positions, as well as avoid the need for continual reorganizations.
This organizational change is welcome news to startups, who often encounter delays while waiting for FDA approval. Super Offices, which have been created over the past decade, are often more efficient as they tend to optimize combined functions that had been taking place in separate departments.
At ADRES, we believe that biopharmaceutical companies and startups involved in the development of cell and gene therapy will see a far more streamlined approval process, with more transparency in the process. Companies should expect to see an expedited drug development and review process, particularly for promising pipeline products.
Discover how we can help you get to market faster! Talk to us today.
