17.03.2024

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 expansion a complex process. Understanding these diverse regulations is key to a successful global presence. Regulatory consultants can provide the expertise needed to navigate these complexities. They help ensure that your products meet the standards of each market you enter.

Strategies for Entering New Markets

Entering new markets requires a well-thought-out strategy. Start by researching the regulatory requirements of your target markets. Then, develop a plan that aligns with these regulations while considering cultural and market differences. Regulatory consultants can offer valuable insights into local regulations and help you tailor your approach accordingly.

Case Studies: Successful Global Expansions

Many biotech companies have successfully expanded globally with the help of regulatory consultation. For example, a biotech firm looking to enter the European market might partner with a consultancy like ADRES. With their expertise, the company can navigate the EU’s regulatory landscape, ensuring a smooth market entry and compliance with local standards.

Tips for Working with International Regulatory Bodies

Working with international regulatory bodies can be daunting. Here are some tips to make the process smoother:

Understand the Local Regulatory Framework: Each country has its own set of rules. Make sure you have a clear understanding of these regulations.
Build Relationships: Establishing a good rapport with regulatory bodies can facilitate smoother interactions and negotiations.
Stay Informed: Regulations can change. Keep yourself updated on any changes in the regulatory landscape.
Seek Expert Guidance: Regulatory consultants can provide invaluable support in navigating international regulations and liaising with regulatory bodies.

In conclusion, regulatory consultation is a vital component of global biotech expansion. It provides the expertise needed to navigate the complex landscape of international regulations, ensuring that your venture can successfully enter new markets and thrive on a global scale. By following these tips and leveraging the knowledge of regulatory consultants, you can set your biotech company up for international success.

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

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12.02.2024

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 and proactive approach to ensure that the sponsors will play a critical role in protecting the participant’s safety and the integrity of clinical trials. This includes increasing the highlight on risk management and quality management systems.

Enhanced Sponsor Quality Assurance:
Version 3 emphasizes a proactive approach to quality management for sponsors and suggests tools and strategies to ensure the highest standards of data integrity, compliance, and overall trial success. This includes recommendations for sponsors to adopt Quality Management Systems, indicating that Sponsor Quality Assurance is adapting and evolving with the clinical research.

Risk-Based Monitoring Integration:
Significant change, allowing sponsors to evaluate how to allocate resources where they are most needed. This ensures sponsors can cultivate a more dynamic and responsive approach to managing study conduct and identifying risks.

Data Integrity and Security:
With an increased focus on data integrity and security, sponsors should be able to protect sensitive information throughout the trial. This not only addresses compliance concerns but also improves the reliability of the data generated.

Continuous Improvement Mindset:
ICH E6 Version 3 asks for continuous improvement from sponsors, expecting them to proactively assess and improve their processes to ensure that sponsors will optimize trial conduct and outcomes.

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

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13.12.2023

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 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.

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03.05.2023

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 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 ‘orphan’ 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 – 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

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09.01.2023

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 greater 0.5 and 5 µm/m3, with instructions to consider 5µm particles measurements where limits are not specified

• 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.

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