Regulatory Affairs

The Regulatory Affairs team is dedicated to supporting client projects through every phase. We manage everything from initial clinical trial start-up activities to securing product registration, Marketing Authorization, and insurance reimbursement.

Our Regulatory Approach

Patient-centered

A patient-centered approach ensures that all our decisions and actions prioritize patient safety and the accessibility of healthcare products. This involves understanding patient needs, maintaining product safety through compliance, and aligning regulatory strategies to drive better patient health outcomes.

Collaborative

We are inherently collaborative, requiring ongoing communication with multiple stakeholders, including health authorities, clients, partners, and internal teams. Our collaborative approach guarantees that all parties work toward the specific regulatory goal of securing approval while maintaining high-quality standards.

Tailored solutions

We develop tailored solutions by customizing strategies to meet the unique regulatory requirements of each market, product, and client. This approach addresses the specific challenges presented by different therapies, countries, and regulatory environments, ensuring compliance and facilitating efficient regulatory approvals.

Data-driven

Our decision-making process is data-driven, integrating scientific, clinical, regulatory, and market data to support the approval process. By leveraging advanced analytics and generating actionable insights, our regulatory affairs team enhances submission strategies, ensures ongoing compliance, and drives continuous improvement across the product lifecycle.

Regulatory in Clinical Trials

Support in the preparation and compilation of regulatory documents.
Verifying that regulatory documents adhere to pertinent guidelines.
Submission to Ethics Committees (EC)
Submission to Competent Authorities (CA)
Follow up
Reports submission

Product Registration (Marketing Authorization)

Regulatory Strategy
Submission Plan Development
Dossier Compilation & Submission through
- Abridged Procedure (AP)
- National Procedure (NP)/Full National Assessment
- Mutual Recognition Procedure (MRP)/Recognition

Technical & Scientific Writing

Our Technical & Scientific Writing services are built through close collaboration with regulatory, technical, and medical professionals. We produce high-quality documents that meet the stringent requirements of the biopharmaceutical industry, including Common Technical Documents (CTD), study protocols, safety reports (DSUR/PBRER, PSUR, PADER), and scientific publications. Our team ensures accuracy, clarity, and compliance, supporting clients' projects from inception to submission with attention to detail and a deep understanding of industry standards.

Regulatory Intelligence

THESYL offers comprehensive Regulatory Intelligence services for biopharmaceutical companies. We provide expert insights into regulatory landscapes, helping you navigate complex compliance requirements and anticipate regulatory changes. Our team ensures your projects align with current regulations and standards, optimizing your pathway to successful product development and market entry. Partner with us for informed decision-making and strategic regulatory planning tailored to your needs.

Partner with us in shaping Health Research and Innovation for Africa

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Terms and Conditions

1. Introduction

Welcome to THESYL AB ("THESYL", "we", "us", or "our"), your trusted partner in Clinical Research, Pharmacovigilance, and Regulatory services across Africa. Incorporated in Sweden, THESYL is committed to advancing healthcare research and innovation by facilitating the development and delivery of safe and effective medicines and therapies tailored to the unique healthcare challenges of the African continent.

These Terms and Conditions ("Terms") govern your use of our website and services. By accessing or using our services, you agree to be bound by these Terms. If you do not agree with any part of these Terms, please refrain from using our services.

2. Definitions

"THESYL" refers to THESYL AB, incorporated in Sweden, and its affiliates.
"Services" refers to the Clinical Research, Pharmacovigilance, and Regulatory services provided by THESYL.
"Client" refers to any individual or organization that engages THESYL for its services.
"User" refers to any individual who accesses or uses our website or services.

3. Services Provided

Clinical Research: Conducting and managing clinical trials to evaluate new therapies and medicines.
Pharmacovigilance: Monitoring, assessing, and reporting on the safety of medicines.
Regulatory Services: Assisting with regulatory submissions and compliance throughout the drug development process.

4. Service Agreements

All engagements with clients are governed by a Service Agreement that outlines the scope, objectives, and deliverables of the services provided. Both parties must review and accept this agreement prior to the commencement of services.

5. Use of Our Website

5.1 Eligibility

You must be at least 18 years old to use our website. By using our website, you represent and warrant that you meet this eligibility requirement.

5.2 License

We grant you a limited, non-exclusive, non-transferable, and revocable license to use our website for personal, non-commercial purposes, subject to these Terms.

5.3 Restrictions

Use our website for any unlawful purpose or in violation of applicable laws.
Reproduce, distribute, modify, or create derivative works of any material on our website.
Engage in any conduct that restricts or inhibits others’ use or enjoyment of our website.

6. Intellectual Property

All content on our website, including text, graphics, logos, images, and software, is the property of THESYL or its content suppliers and is protected by applicable intellectual property laws.

7. Privacy

Your use of our website is also governed by our Privacy Policy, which outlines the collection, use, and disclosure of your personal information. By using our website, you consent to these practices as outlined in our Privacy Policy, available at www.thesyl.se/privacy.

8. Client Obligations

Clients must provide accurate and complete information necessary for THESYL to perform its services. Clients are responsible for complying with all applicable laws and regulations related to the services provided.

9. Confidentiality

THESYL is committed to safeguarding the confidentiality of all client information. We will not disclose any confidential information to third parties without the client’s consent, except as required by law.

10. Payment Terms

Fees for services are outlined in the Service Agreement. Clients must adhere to the payment terms specified in the agreement. Late payments may incur additional charges.

11. Disclaimers

11.1. No Warranties

Our website and services are provided on an “as is” and “as available” basis without any warranties of any kind, either express or implied. THESYL disclaims all warranties, including but not limited to, implied warranties of merchantability, fitness for a particular purpose, non-infringement, and availability. Terms & Conditions

12. Limitation of Liability

To the fullest extent permitted by law, THESYL will not be liable for any indirect, incidental, special, consequential, or punitive damages, including but not limited to, loss of profits, data, use, goodwill, or other intangible losses, resulting from your use or inability to use our website or services.

13. Indemnification

You agree to indemnify, defend, and hold harmless THESYL, its affiliates, officers, directors, employees, agents, licensors, and suppliers from and against any claims, liabilities, damages, judgments, awards, losses, costs, expenses, or fees (including reasonable attorneys’ fees) arising out of or relating to your violation of these Terms or your use of our website.

14. Governing Law

These Terms and Conditions and any Service Agreement shall be governed by and construed in accordance with the laws of Sweden.

15. Dispute Resolution

Any disputes arising out of or related to these Terms and Conditions or the Service Agreement will be resolved through binding arbitration in accordance with the rules of the Arbitration Institute of the Stockholm Chamber of Commerce.

16. Amendments

We may update these Terms from time to time in our sole discretion. All changes are effective immediately when we post them and apply to all access to and use of our website thereafter. Clients will be notified of any changes, and continued use of our website and services following the posting of revised Terms means that you accept and agree to the changes.

17. Contact Information

For any questions or concerns, please contact us:

THESYL AB

Org No: 559393-6262

Address: 754 40 Uppsala, Sweden

Phone: +46 76 907 14 80

Email: info@thesyl.se

Privacy Policies

Last updated: 05/08/2024

1. Introduction

THESYL AB (“we,” “us,” or “our”) is committed to protecting your privacy. This Privacy Policy explains how we collect, use, disclose, and safeguard your information when you visit our website www.thesyl.se or use our services. Please read this Privacy Policy carefully. If you do not agree with the terms of this Privacy Policy, please do not access the site.

2. Information We Collect

We may collect information about you in a variety of ways. The information we may collect on the site includes:

Personal Data: Personally identifiable information, such as your name, shipping address, email address, and telephone number, and demographic information, such as your age, gender, hometown, and interests, that you voluntarily give to us when you register with the site or participate in various activities related to the site, such as online chat and message boards.
Derivative Data: Information our servers automatically collect when you access the site, such as your IP address, your browser type, your operating system, your access times, and the pages you have viewed directly before and after accessing the site.
Financial Data: Financial information, such as data related to your payment method (e.g., valid credit card number, card brand, expiration date) that we may collect when you purchase, order, return, exchange, or request information about our services from the site.
Data from Social Networks: User information from social networking sites, such as Facebook, Google+, Instagram, including your name, your social network username, location, gender, birth date, email address, profile picture, and public data for contacts, if you connect your account to such social networks.

3. Use of Your Information

Having accurate information about you permits us to provide you with a smooth, efficient, and customized experience. Specifically, we may use information collected about you via the site to:

Create and manage your account.
Process your transactions and send you related information, including purchase confirmations and invoices.
Improve our website and services.
Send you marketing and promotional communications.
Respond to your comments, questions, and requests and provide customer service.
Monitor and analyze usage and trends to improve your experience with the site.
Prevent fraudulent transactions, monitor against theft, and protect against criminal activity.
Notify you of updates to the site and our services.
Request feedback and contact you about your use of the site.
Resolve disputes and troubleshoot problems.

4. Disclosure of Your Information

We may share information we have collected about you in certain situations. Your information may be disclosed as follows:

By Law or to Protect Rights: If we believe the release of information about you is necessary to respond to legal process, to investigate or remedy potential violations of our policies, or to protect the rights, property, and safety of others, we may share your information as permitted or required by any applicable law, rule, or regulation.
Third-Party Service Providers: We may share your information with third parties that perform services for us or on our behalf, including payment processing, data analysis, email delivery, hosting services, customer service, and marketing assistance.
Marketing Communications: With your consent, or with an opportunity for you to withdraw consent, we may share your information with third parties for marketing purposes, as permitted by law.
Business Transfers: We may share or transfer your information in connection with, or during negotiations of, any merger, sale of company assets, financing, or acquisition of all or a portion of our business to another company.
Affiliates: We may share your information with our affiliates, in which case we will require those affiliates to honor this Privacy Policy. Affiliates include our parent company and any subsidiaries, joint venture partners, or other companies that we control or that are under common control with us.
Business Partners: We may share your information with our business partners to offer you certain products, services, or promotions.
Other Third Parties: We may share your information with advertisers and investors for the purpose of conducting general business analysis.

5. Tracking Technologies

We may use cookies, web beacons, tracking pixels, and other tracking technologies on the site to help customize the site and improve your experience. When you access the site, your personal information is not collected through the use of tracking technology. Most browsers are set to accept cookies by default. You can remove or reject cookies, but be aware that such action could affect the availability and functionality of the site.

6. Security of Your Information

We use administrative, technical, and physical security measures to help protect your personal information. While we have taken reasonable steps to secure the personal information you provide to us, please be aware that despite our efforts, no security measures are perfect or impenetrable, and no method of data transmission can be guaranteed against any interception or other type of misuse.

7. Policy for Children

We do not knowingly solicit information from or market to children under the age of 18. If we learn that we have collected personal information from a child under age 18 without verification of parental consent, we will delete that information as quickly as possible.

8. Controls for Do-Not-Track Features

Most web browsers and some mobile operating systems include a Do-Not-Track (“DNT”) feature or setting you can activate to signal your privacy preference not to have data about your online browsing activities monitored and collected. No uniform technology standard for recognizing and implementing DNT signals has been finalized. As such, we do not currently respond to DNT browser signals or any other mechanism that automatically communicates your choice not to be tracked online.

9. Options Regarding Your Information

You may at any time review or change the information in your account or terminate your account by:

Logging into your account settings and updating your account.
Contacting us using the contact information provided below.

Upon your request to terminate your account, we will deactivate or delete your account and information from our active databases. However, some information may be retained in our files to prevent fraud, troubleshoot problems, assist with any investigations, enforce our Terms of Use and/or comply with legal requirements.

10. International Data Transfers

We may transfer, store, and process your information in countries other than your own, including Sweden, Rwanda, and other countries where our affiliates and service providers are located. When we transfer your information internationally, we will ensure that your information is protected in accordance with this Privacy Policy and applicable privacy laws.

11. Legal Basis for Processing

If you are a resident of the European Economic Area (EEA), the United Kingdom (UK), or Switzerland, we process your personal information in accordance with the General Data Protection Regulation (GDPR) and other applicable data protection laws. If you are a resident of Rwanda, we process your personal information in accordance with the Rwanda Data Protection and Privacy Law and other applicable laws.

12. Contact Us

If you have questions or comments about this Privacy Policy, please contact us at:

THESYL AB
Org No: 559393-6262
Address: 754 40 Uppsala, Sweden
Phone: +46 76 907 14 80
Email: info@thesyl.se

13. Changes to This Privacy Policy

We may update this Privacy Policy from time to time in order to reflect, for example, changes to our practices or for other operational, legal, or regulatory reasons.

14. Additional Information

Data Retention: We will retain your personal information only for as long as is necessary to fulfil the purposes outlined in this Privacy Policy unless a longer retention period is required or permitted by law.