Regulatory Affairs & Ethical Dossier
Regulatory Affairs &
Ethical Dossier
Our highly experienced team identifies the best regulatory strategy for your product, outlining the most appropriate pathway within the local regulatory landscape and with the main regulatory authorities.
Strategy, dossiers, and ongoing support for the product lifecycle
Regulatory strategies
Definition of integrated regulatory strategies, aligned with the product profile, stage of development, and requirements of health authorities.
Interactions with regulatory agencies
Technical guidance and support in interactions with regulatory authorities and ethics committees, including technical meetings, responses to requirements, and follow-up.
Regulatory feasibility assessment
Analysis of the regulatory and ethical feasibility of clinical projects, considering local requirements, risks, timelines, costs, and strategic alternatives for facilitating the study or product registration.
Gap Analysis / Due Diligence
Conducting Gap Analysis and regulatory Due Diligence to identify inconsistencies, risks, and opportunities for technical compliance, ensuring adherence.
Preparation of dossiers
Preparation, review, and submission of complete regulatory dossiers, including CTD, DDCM, and DEEC, ensuring technical consistency and document quality.
Regulatory lifecycle management
Continuous management of the product life cycle, covering regulatory updates, variations, renewals, amendments, record keeping, and post-submission support.
Regulatory strategies
Definition of integrated regulatory strategies, aligned with the product profile, stage of development, and requirements of health authorities.
Interactions with regulatory agencies
Technical guidance and support in interactions with regulatory authorities and ethics committees, including technical meetings, responses to requirements, and follow-up.
Regulatory feasibility assessment
Analysis of the regulatory and ethical feasibility of clinical projects, considering local requirements, risks, timelines, costs, and strategic alternatives for facilitating the study or product registration.
Gap Analysis / Due Diligence
Conducting Gap Analysis and regulatory Due Diligence to identify inconsistencies, risks, and opportunities for technical compliance, ensuring adherence.
Preparation of dossiers
Preparation, review, and submission of complete regulatory dossiers, including CTD, DDCM, and DEEC, ensuring technical consistency and document quality.
Regulatory lifecycle management
Continuous management of the product life cycle, covering regulatory updates, variations, renewals, amendments, record keeping, and post-submission support.
Regulatory strategies
Definition of integrated regulatory strategies, aligned with the product profile, stage of development, and requirements of health authorities.
Interactions with regulatory agencies
Technical guidance and support in interactions with regulatory authorities and ethics committees, including technical meetings, responses to requirements, and follow-up.
Regulatory feasibility assessment
Analysis of the regulatory and ethical feasibility of clinical projects, considering local requirements, risks, timelines, costs, and strategic alternatives for facilitating the study or product registration.
Gap Analysis / Due Diligence
Conducting Gap Analysis and regulatory Due Diligence to identify inconsistencies, risks, and opportunities for technical compliance, ensuring adherence.
Preparation of dossiers
Preparation, review, and submission of complete regulatory dossiers, including CTD, DDCM, and DEEC, ensuring technical consistency and document quality.
Regulatory lifecycle management
Continuous management of the product life cycle, covering regulatory updates, variations, renewals, amendments, record keeping, and post-submission support.
Regulatory strategies
Definition of integrated regulatory strategies, aligned with the product profile, stage of development, and requirements of health authorities.
Interactions with regulatory agencies
Technical guidance and support in interactions with regulatory authorities and ethics committees, including technical meetings, responses to requirements, and follow-up.
Regulatory feasibility assessment
Analysis of the regulatory and ethical feasibility of clinical projects, considering local requirements, risks, timelines, costs, and strategic alternatives for facilitating the study or product registration.
Gap Analysis / Due Diligence
Conducting Gap Analysis and regulatory Due Diligence to identify inconsistencies, risks, and opportunities for technical compliance, ensuring adherence.
Preparation of dossiers
Preparation, review, and submission of complete regulatory dossiers, including CTD, DDCM, and DEEC, ensuring technical consistency and document quality.
Regulatory lifecycle management
Continuous management of the product life cycle, covering regulatory updates, variations, renewals, amendments, record keeping, and post-submission support.
Regulatory strategies
Definition of integrated regulatory strategies, aligned with the product profile, stage of development, and requirements of health authorities.
Interactions with regulatory agencies
Technical guidance and support in interactions with regulatory authorities and ethics committees, including technical meetings, responses to requirements, and follow-up.
Regulatory feasibility assessment
Analysis of the regulatory and ethical feasibility of clinical projects, considering local requirements, risks, timelines, costs, and strategic alternatives for facilitating the study or product registration.
Gap Analysis / Due Diligence
Conducting Gap Analysis and regulatory Due Diligence to identify inconsistencies, risks, and opportunities for technical compliance, ensuring adherence.
Preparation of dossiers
Preparation, review, and submission of complete regulatory dossiers, including CTD, DDCM, and DEEC, ensuring technical consistency and document quality.
Regulatory lifecycle management
Continuous management of the product life cycle, covering regulatory updates, variations, renewals, amendments, record keeping, and post-submission support.
Synvia
Why choose Synvia
More than two decades of experience across the entire drug research and registration chain.
We integrate clinical research, laboratory analyses, and technology to meet the demands of the pharmaceutical industry with quality and global compliance.
CRO Services
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Contact
Talk to our experts
Discover how Synvia can support your studies, analyses, and projects.
Contact
Talk to our experts
Discover how Synvia can support your studies, analyses, and projects.