Regulatory Affairs at Chiron Medical

Your Regulatory Journey, Our Expertise – Choose Success, Choose Chiron Medical.

Chiron Medical recognizes the importance of submitting excellent applications to the Turkish Medicines and Medical Devices Agency (TMMDA) and local Ethics Committees (ECs) in order to guarantee prompt approvals. We have experts on the ground with the necessary up-to-date local knowledge of the submission process in Turkiye. TMMDA and Ethics Committee submissions will be handled by Chiron Medical specialists to ensure a smooth transition from approval to study start-up. Each member of our team possesses extensive practical knowledge of preparing TMMDA and Ethics Committee submissions. Chiron Medical experts possess extensive knowledge of all the nuances involved in each process, enabling them to interact with the TMMDA and Ethics Committee with ease. They have successfully completed submissions in some of the most difficult regulatory environments.
Chiron Medical guarantees that every regulatory submission is customized to your trial's unique requirements and satisfies the highest standards.

With our experienced regulatory affairs service, we provide customers conducting clinical trials in Turkiye with expert guidance, ensuring adherence to local regulatory standards and facilitating a seamless path for their research initiatives.

At Chiron Medical, we specialize in the thorough preparation of regulatory packages for clinical trials, addressing both the Turkish Medicines and Medical Devices Agency (TMMDA) and Ethics Committee (EC) requirements, ensuring a comprehensive and compliant submission process for our cutting-edge medical advancements.

Initial applications for the studies below;

  • Phase I, II, III and IV Clinical Trials
  • Low-Risk Scientific Studies
  • Adaptive Designs (Phase I/II, Phase I/III, Phase II/III) Clinical Trials
  • Expanded Access (Compassionate Use) Trials
  • Bioavailability and Bioequivalence Studies
  • Medical Device Clinical Trials / Studies
  • Performance Evaluation Studies Conducted with In-Vitro Medical Diagnostic Devices
  • Observational Studies including Cohort, Case-Control, Cross-Sectional, Longitudinal, Retrospective, Prospective, Ecological Studies, Cross-Sectional Surveys, Registry Studies, Comparative Effectiveness Research (CER), Descriptive, Population-based, Surveillance and Epidemiological Studies

Types of Amendments/Changes;

  • Change in principal investigator
  • Extension of the insurance period
  • Change in patient card/diary used in approved trial/study.
  • Extension of the trial/study period
  • Extension of the volunteer recruitment period
  • Change in CRF after first initial approvals are granted
  • Change in IB not requiring changes in ICFand protocol
  • Documents that will not be applicable in our country and do not contain information about the safety statement

Types of Substantial Amendments/Changes;

  • Change in the information in the application form
  • Amendment in trial/study protocol
  • Amendment in informed consent form
  • Amendment in Investigator’s Brochure (IB) (those that require approval from the TMMDA in accordance with the relevant legislation)
  • Amendment in trial budget form
  • Amendment  in insurance (excluding extension)
  • Increase in the number of volunteers planned to be included in our country
  • Amendment in the documents given to the volunteer / patient
  • Amendment in emergency security measures
  • Temporary suspension of the study
  • Request to restart the trial
  • Amendment in safety or health status of volunteers
  • Amendment in the quality of the investigational product
  • Amendment in the conduct or management of the trial
  • Amendment in coordinator (change of principal investigator in single-center studies)
  • Change in administrative responsible 
  • Change in sponsor
  • Change in legal representative
  • Addition of site(s)
  • Site removal / closure
  • Change in the transfer of basic trial/study tasks
  • Other changes (other changes considered by the Sponsor as substantial amendment/change)

Types of Notifications;

  • Trial/Study Initiation Date 
  • First Volunteer First Visit Date
  • End Date of Volunteer Recruitment 
  • Annual Notification (Progress Report)
  • Personnel Assignment(s)
  • Safety Notifications; Suspected fatal or life threatening unexpected serious adverse reactions (SUSAR), Other suspected unexpected serious adverse reactions (SUSAR), Completion report, Follow-up report, SUSAR line listing, Annual safety report (ASR), Development safety update report (DSUR)
  • Early Termination or Termination of Trial/Study
  • Trial/Study Final Report

Applications for the import of investigational products are made in accordance with the “Guidelines on the Import of Investigational Products to be Used in Clinical Trials”.

Applications for investigator meetings are made in accordance with the “Clinical Research Investigator Meeting Application Guide”.

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Overview of Regulatory Affairs at Chiron Medical

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Chiron Medical's regulatory affairs team employs a proactive and strategic approach to navigate the intricacies of regulatory frameworks, minimizing delays in clinical trial approvals.

Managing clinical trial applications and notifications in Turkiye involves a thorough understanding of the regulatory framework and ethical considerations. The Turkish Medicines and Medical Devices Agency (TMMDA) is the regulatory authority responsible for overseeing clinical trials in our country, and the ethical aspects are governed by local ethics committees. Below is a detailed overview of our process:

Chiron Medical begins by conducting thorough regulatory intelligence to understand the specific requirements and regulations governing clinical trials in Turkiye. This includes staying updated on any recent changes in laws, guidelines, or procedures set by the Turkish Medicines and Medical Devices Agency (TMMDA) and other relevant regulatory bodies.

Based on the regulatory intelligence gathered, Chiron Medical collaborates with the sponsor to develop a strategic plan for regulatory submissions in Turkiye. This plan outlines timelines, document requirements, and key milestones in the submission process.

Chiron Medical assists the sponsor in preparing the necessary regulatory documents required for clinical trial submissions. This includes Clinical Trial Application (CTA) dossier, which includes essential documents such as the protocol, investigator’s brochure, informed consent forms, and other relevant materials. Chiron Medical ensures that these documents adhere to the local regulatory requirements and guidelines.

Since regulatory documents must often be submitted in the local language, Chiron Medical provides translation services to ensure that protocol or protocol synopsis, informed consent forms, and other relevant documents are accurately translated into Turkish to meet regulatory language requirements.

Chiron Medical performs the submission of regulatory documents to TMMDA. This involves preparing and submitting the CTA dossier and any required forms, ensuring compliance with submission formats and electronic submission requirements.

General approach is to select the national coordinating investigator and his/her site for a study, and proceed with this facility’s EC thereby receiving the investigator’s support. Currently, there are 120 ethics committees in Turkiye, with nearly half of them located in the three big cities – Istanbul (38), Ankara (18) and Izmir (7). In parallel, the CRO assists in preparing and submitting documents to the local ethics committee responsible for reviewing and approving the ethical aspects of the clinical trial.

Throughout the review process, Chiron Medical acts as a liaison between the sponsor and regulatory authorities. They address any queries or requests for additional information and ensure that responses are provided in a timely and comprehensive manner.

Chiron Medical provides regular updates to the sponsor on the status of regulatory submissions and any interactions with regulatory authorities. This transparency helps the sponsor stay informed about the progress of the regulatory affairs process. We ensure that the study adheres to Good Clinical Practice (GCP) guidelines, study protocol and local regulations and guidelines. Regulatory environments are dynamic, and Chiron Medical must be vigilant in adapting to any changes in regulations or guidelines during the course of the clinical trial.

Chiron Medical assists in the clinical trial agreements negotiation and finalization of clinical trial agreements with clinical trial sites while trial is being evaluted initially by TMMDA and Ethics Committee. Chiron Medical ensures that these agreements meet legal and regulatory standards and align with local regulations.

Chiron Medical reviews the clinical trial protocol to ensure it complies with local regulations. If any amendments are necessary, Chiron Medical assists in preparing and submitting protocol amendments for timely regulatory approval of any changes to the study protocol. Protocol Synopsis with study flow chart should be translated to Turkish by expert translators in Turkiye. 

Chiron Medical supports the sponsor in adhering to safety reporting requirements, ensuring that all safety-related information is submitted to regulatory authorities as per the regulatory guidelines.

After obtaining TMMDA and EC approval/permission, Chiron Medical manages import/export requirements for investigational products, ensuring that all shipments comply with local regulations and guidelines.

After initial approval is obtained from TMMDA and EC, Chiron Medical continues to support the sponsor in maintaining compliance with regulatory requirements throughout the conduct of the clinical trial.

Since regulatory environments are dynamic, Chiron Medical is vigilant in adapting to any changes in regulations or guidelines during the course of the clinical trial. Chiron Medical oversees regulatory close-out activities, including the preparation of final reports and the archiving of essential documents.

Throughout these processes, effective communication and collaboration between Chiron Medical, sponsor, regulatory authorities, and trial sites are crucial. Chiron Medical’s role is to navigate the regulatory landscape, streamline the submission process, and ensure compliance with local regulations and guidelines, thereby facilitating the successful initiation and conduct of clinical trials in Turkiye.

Our Regulatory Consulting Services In Turkiye Portfolio Covers:

Chiron Medical sets a benchmark in regulatory services, demonstrating unwavering dedication to compliance and patient safety across a spectrum of medical products. Their regulatory approach is characterized by meticulous assessments, ensuring an in-depth understanding of the regulatory landscape in Turkiye. The dedicated regulatory team at Chiron Medical orchestrates the thorough preparation of documentation, encompassing detailed specifications, safety profiles, and essential clinical data for diverse medical products. Recognizing the importance of local representation, the company aligns with Turkish regulatory requirements, facilitating the submission of comprehensive applications to regulatory authorities. Whether for pharmaceuticals, medical devices, or other healthcare products, Chiron Medical’s regulatory prowess is evident in the successful authorization of products, reflecting their commitment to delivering innovative, high-quality, and compliant medical solutions to the Turkish market. Post-authorization, Chiron Medical remains steadfast in its commitment to continuous compliance, rigorous pharmacovigilance, and strict adherence to labeling and packaging guidelines, ensuring a seamless integration of medical products into the Turkish healthcare landscape.

Securing new product authorizations for pharmaceuticals at Chiron Medical in Turkiye is a meticulous process guided by the company’s commitment to compliance and patient safety. Chiron Medical’s regulatory team conducts a comprehensive assessment, meticulously navigating Turkiye’s pharmaceutical regulatory landscape to ensure a nuanced understanding of relevant laws and standards. The documentation preparation phase is approached with precision, requiring the compilation of extensive data, including detailed product specifications, safety profiles, and clinical trial results. Chiron Medical understands the significance of appointing a local representative or authorized agent, where necessary, to align with Turkish regulatory requirements. The company submits thorough applications to the Turkish Medicines and Medical Devices Agency (TITCK), initiating a stringent review process that focuses on the product’s efficacy, safety, and conformity with Turkish pharmaceutical regulations. Successful applications result in the issuance of marketing authorizations, a testament to Chiron Medical’s commitment to delivering innovative and compliant pharmaceutical solutions to the Turkish market. Post-authorization, Chiron Medical remains dedicated to ensuring ongoing compliance, vigilant pharmacovigilance, and adherence to labeling and packaging guidelines, underscoring their commitment to regulatory excellence and patient welfare in Turkiye.

Chiron Medical’s Strategic Regulatory Consulting services represent a pinnacle of expertise and commitment to navigating the complex regulatory landscape for various medical products. Leveraging a deep understanding of Turkish regulations, the seasoned consultants at Chiron Medical provide invaluable insights and strategic guidance to facilitate seamless market entry. From pharmaceuticals to medical devices, their approach is comprehensive, ensuring tailored regulatory strategies that not only secure initial authorizations but also foster sustained compliance and adaptability to evolving regulatory environments. Chiron Medical’s commitment extends beyond approval processes, encompassing ongoing compliance, proactive engagement with regulatory updates, and strategic positioning for long-term success in the dynamic Turkish healthcare market. Their dedication to innovation, regulatory excellence, and patient safety makes Chiron Medical a trusted partner for companies seeking strategic regulatory consulting for diverse medical products in Turkiye.

Chiron Medical excels in guiding Marketing Authorization applications for a comprehensive spectrum of medical products, encompassing pharmaceuticals, biotechnology products, and biologicals. Leveraging their extensive regulatory expertise, the company orchestrates meticulous and strategic approaches for successful applications in Turkiye. The regulatory team at Chiron Medical conducts thorough assessments, ensuring compliance with Turkish regulations and standards. Whether navigating the complex pathways for traditional pharmaceuticals or cutting-edge biotechnology and biological products, Chiron Medical demonstrates a commitment to excellence. Their comprehensive approach spans from documentation preparation, including rigorous clinical data, to strategic engagement with regulatory authorities, culminating in the successful authorization of diverse medical products. Post-authorization, Chiron Medical remains dedicated to ensuring ongoing compliance, pharmacovigilance, and adherence to evolving regulatory requirements, positioning them as a trusted partner for companies seeking Marketing Authorization for a broad range of medical products in the Turkish market.

Chiron Medical distinguishes itself as a leading expert in handling all types of variation applications for diverse medical products. Whether for pharmaceuticals, biotechnology products, or other medical innovations, Chiron’s regulatory team navigates the intricacies of variation applications with precision. Their comprehensive approach encompasses changes in formulations, manufacturing processes, labeling, or any modifications necessary for regulatory compliance. Chiron Medical not only ensures the seamless submission of variation applications but also provides strategic guidance to address regulatory challenges effectively. With a commitment to excellence, the company facilitates the approval of variations, ensuring that all modifications align with the stringent regulatory standards in Turkiye. This expertise positions Chiron Medical as a trusted partner for companies seeking adept handling of variation applications for their medical products in the Turkish market.

Chiron Medical sets the gold standard in Post-Approval Life Cycle Management, offering comprehensive solutions for a diverse array of medical products. With an unwavering commitment to regulatory excellence, Chiron’s dedicated team ensures the seamless integration of products into the Turkish market post-approval. Their strategic approach includes ongoing compliance monitoring, proactive engagement with regulatory updates, and strategic adjustments to evolving requirements. Chiron Medical’s expertise extends beyond initial authorizations, addressing changes in formulations, labeling, and manufacturing processes with precision. Through a dynamic and adaptable approach, Chiron facilitates sustained regulatory compliance and strategic product positioning throughout its life cycle. As a trusted partner, Chiron Medical exemplifies a commitment to excellence in managing the post-approval life cycle of various medical products in the Turkish healthcare landscape.

Chiron Medical stands at the forefront of regulatory excellence, offering unparalleled expertise in Regulatory Strategies and Expert Views for a diverse range of medical products. Leveraging their in-depth knowledge of Turkish regulations, the company provides strategic insights to navigate the complex regulatory landscape effectively. Whether dealing with pharmaceuticals, biotechnology products, or other medical innovations, Chiron’s expert team crafts tailored regulatory strategies, ensuring compliance and facilitating successful product approvals. Their commitment extends beyond approval processes, offering ongoing expert guidance to address regulatory challenges, adapt to evolving requirements, and strategically position medical products in the Turkish market. Chiron Medical’s dedication to regulatory excellence and continuous support makes them an indispensable partner for companies seeking sound regulatory strategies and expert perspectives for their medical products in Turkiye.

Chiron Medical stands as a beacon of expertise in Regulatory Affairs and Regulatory Intelligence, offering comprehensive solutions for a diverse array of medical products. Leveraging an in-depth understanding of Turkish regulatory frameworks, the company’s dedicated team provides strategic insights and intelligence to navigate the intricate regulatory landscape effectively. Whether dealing with pharmaceuticals, biotechnology products, or other medical innovations, Chiron Medical excels in crafting tailored regulatory strategies, ensuring compliance, and facilitating successful product approvals. Their commitment extends to continuous regulatory monitoring, providing clients with up-to-date intelligence on regulatory changes, ensuring proactive adaptation to evolving requirements. As a trusted partner, Chiron Medical exemplifies a commitment to excellence in Regulatory Affairs and Regulatory Intelligence, guiding medical product companies through the complexities of the Turkish regulatory landscape.

Chiron Medical stands as a pinnacle in Life Cycle Management, offering an extensive suite of services tailored to diverse medical products. Going beyond the initial regulatory milestones, Chiron excels in strategically managing the entire life cycle of medical products. With a steadfast commitment to regulatory excellence, their dedicated team ensures ongoing compliance, proactively adapting to evolving regulatory landscapes. Chiron’s expertise spans adeptly navigating changes in formulations, manufacturing processes, and labeling, optimizing product positioning in the dynamic Turkish healthcare market. As a trusted partner, Chiron Medical’s comprehensive approach to Life Cycle Management reflects a commitment to sustained success and regulatory adherence for a broad spectrum of medical products, making them an invaluable ally for companies seeking long-term support in the Turkish healthcare sector.

Chiron Medical is a leading provider of Pharmacovigilance Services, offering comprehensive solutions for a diverse range of medical products. With a steadfast commitment to patient safety, Chiron’s dedicated pharmacovigilance team meticulously monitors and assesses the safety profiles of pharmaceuticals, biotechnology products, and various medical innovations. The company ensures strict compliance with Turkish regulations, promptly identifies and evaluates adverse events, and implements proactive risk management strategies. Chiron’s vigilance extends throughout the life cycle of each product, demonstrating an unwavering commitment to ongoing safety monitoring and regulatory adherence. As a trusted partner, Chiron Medical plays a pivotal role in maintaining and enhancing the safety standards of medical products in the Turkish market, fostering confidence and well-being among patients and healthcare professionals.

 
 
 
 
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