Regulatory Affairs

Welcome to our Homepage - Regulatory Affairs!

At Interdos Pharma we have a professional regulatory affairs consulting department specializing in providing comprehensive and strategic advice on regulatory strategy and EU legislation for pharmaceuticals and medical devices. We pride ourselves on delivering high-quality, timely, and strategic regulatory affairs services to support your product development, registration and regulatory compliance needs. Our team of experienced regulatory experts has extensive experience in navigating the complex regulatory landscape and can provide tailored solutions to meet your specific requirements.

We can assist you with all aspects of regulatory affairs, whether you are seeking advice on regulatory strategy, dossier preparation and submission, maintenance and variations, eCTD registration dossiers, label and leaflet compilation, readability testing, assessment of registration dossiers, applications for scientific advice, change of legal status, biosimilars, vaccines, medical devices in compliance with the Medical Device Regulation, or CE marking, our team is ready to assist you.

Contact us today to learn how our regulatory affairs services can help you achieve regulatory compliance, optimize your product development strategies, and successfully navigate the regulatory requirements for your products. Trust us to be your partner in regulatory affairs, ensuring your products meet the highest standards of regulatory compliance.

Our Services Include:

Advice on regulatory strategy and EU legislation: Our team can provide strategic guidance on navigating the complex regulatory landscape, including interpreting and implementing EU legislation, to help you achieve regulatory compliance and optimize your product development and commercialization strategies.

Regulatory due diligence/Assessment of registration dossiers: We can conduct thorough regulatory due diligence assessments to identify and mitigate potential regulatory risks associated with your products, including evaluating compliance with applicable regulations, identifying gaps in documentation, and assessing potential impact on regulatory status.

Dossier preparation, submission, maintenance, and variations: We can assist with the preparation and submission of regulatory dossiers for national, Mutual Recognition Procedure (MRP), and Decentralized Procedure (DCP) submissions, as well as provide ongoing maintenance and management of regulatory dossiers. We can also help with variations, such as changes to the product information, labeling, and other regulatory updates.

Development and updating of eCTD registration dossiers: Our team is well-versed in the requirements for electronic Common Technical Document (eCTD) format, and can assist with the development, submission, and updating of eCTD registration dossiers, ensuring compliance with the latest regulatory guidelines.

Compilation of Modules 2.3, 2.4 and 2.5: We can compile and review the nonclinical and clinical sections of the Common Technical Document (CTD) for Modules 2.3, 2.4, and 2.5, including the Quality Overall Summary (QOS), Nonclinical Overview (NCO), Clinical Overview (CO), and Clinical Summary (CS) documents, to support your product registration and regulatory submissions.

Compilation of labels, leaflets, SmPC, and mock-ups: We can provide expert assistance in the compilation, review, and approval of product labels, leaflets, Summary of Product Characteristics (SmPC), and mock-ups, ensuring compliance with regulatory requirements, guidelines, and local language requirements.

Readability testing of Patient Information Leaflets: We can conduct readability testing (in cooperation with an experienced external party) of Patient Information Leaflets (PILs) to ensure that they are clear, understandable, and meet regulatory requirements for patient information, helping to improve patient safety and compliance.

Assessment of registration dossiers: Our team can conduct comprehensive assessments of registration dossiers to identify any gaps or deficiencies, and provide recommendations for improvement to ensure regulatory compliance and successful registration of your products.

Applications for scientific advice: We can assist with the preparation and submission of applications for scientific advice to regulatory authorities, providing strategic guidance and expertise in navigating the regulatory advice process to optimize your product development strategies.

Change of Legal status: We can provide guidance and support in managing change of legal status for your products, such as switches from prescription to over-the-counter (OTC) status, or changes in legal classification, helping you navigate the regulatory requirements and achieve successful transitions.

Biologicals, biosimilars and vaccines: We can provide expert guidance on regulatory requirements and strategic advice for biologicals, biosimilars and vaccines, including dossier preparation, submission, and maintenance, as well as compliance with relevant guidelines and regulations.

Medical devices in compliance with the Medical Device Regulation (MDR): Our team is well-versed in the regulatory requirements for medical devices in compliance with the Medical Device Regulation (MDR), we have a PRRC in-house, including Advice how to perform the self-certification according to MDR. We can provide guidance on classification, conformity assessment, labeling, and other regulatory aspects specific to medical devices, helping you achieve compliance and successful market access. And preparing a technical file for submission to authorities.

CE marking: We can assist with the CE marking process for medical devices, including preparation of technical documentation, conformity assessment, and regulatory submissions, ensuring compliance with the MDR requirements for CE marking and facilitating market access in the European Union (EU).

Contact us today to learn more about our services and how we can support your regulatory needs.