Publishing Service
eCTD (electronic Common Technical Document) publishing and submission services refer to the processes and services involved in preparing, formatting, and submitting regulatory documents to health authorities in electronic format, following the eCTD standard.
Transforming dossiers into CTD format, whether in the form of NeeS or eCTD, and harnessing eCTD tools to facilitate the publishing (Both document level and submission level) of initial applications, responses to queries, variation documents, and aggregate reports. Effectively overseeing eCTD submissions through agency web portals or gateways, all the while guaranteeing the consistent maintenance of a product-specific filing sequence for both the initial submission and responses to queries.
Lifecycle Management of submissions by creating and submitting Pre INDs, INDs, NDA, ANDA, BLA, Briefing Package, MAA, MRP, DCP, NP, amendments, supplements, Variations, Annual Reports, Renewals, Work sharing, pSUSA, PSUR, Core Package for US, EU and other global markets in eCTD format as required by health authorities.
Regulatory Strategy: This includes planning for regulatory submissions(Drug Substance and Drug Product), timelines, and compliance with evolving regulatory standards.
Regulatory Labeling:–
Our team of experts specializes in meticulously reviewing labeling documents to ensure strict compliance with regulatory standards. Through thorough assessments, we provide essential recommendations for adjustments, guaranteeing that the labeling information aligns seamlessly with the stringent requirements outlined by regulatory authorities. The significance of precise product labeling cannot be overstated, as it is the primary means to accurately convey critical product details tohealthcare professionals and consumers alike. Any inaccuracies or errors in labeling can introduce risks across various domains, including non-compliance issues, threats to patient and consumer safety, and the potential necessity for costly product recalls—a burden that pharmaceutical manufacturers aim to avoid at all costs. Therefore, it remains imperative for pharmaceutical companies to maintain a close collaboration with regulatory compliance standards throughout the development of pharmaceutical labels for their products.
1. Our comprehensive services encompass the management and approval of product labels, including SPC (Summary of Product Characteristics), PIL (Patient Information Leaflets), PI (Package Inserts), mock- ups, Carton/Containers labels, medication guides and Side by side comparison.
We excel in efficiently handling variations stemming from labeling changes and country-specific labeling requirements. Our expertise extends to rigorous labeling change management and the meticulous review and compliance analysis of labeling manuscripts. Providing regulatory submissions in electronic format.
Regulatory Labeling:–
Our team of experts specializes in meticulously reviewing labeling documents to ensure strict compliance with regulatory standards. Through thorough assessments, we provide essential recommendations for adjustments, guaranteeing that the labeling information aligns seamlessly with the stringent requirements outlined by regulatory authorities. The significance of precise product labeling cannot be overstated, as it is the primary means to accurately convey critical product details tohealthcare professionals and consumers alike. Any inaccuracies or errors in labeling can introduce risks across various domains, including non-compliance issues, threats to patient and consumer safety, and the potential necessity for costly product recalls—a burden that pharmaceutical manufacturers aim to avoid at all costs. Therefore, it remains imperative for pharmaceutical companies to maintain a close collaboration with regulatory compliance standards throughout the development of pharmaceutical labels for their products.
1. Our comprehensive services encompass the management and approval of product labels, including SPC (Summary of Product Characteristics), PIL (Patient Information Leaflets), PI (Package Inserts), mock- ups, Carton/Containers labels, medication guides and Side by side comparison.
We excel in efficiently handling variations stemming from labeling changes and country-specific labeling requirements. Our expertise extends to rigorous labeling change management and the meticulous review and compliance analysis of labeling manuscripts. Providing regulatory submissions in electronic format.
Artwork Management-
Artwork management in the pharmaceutical industry is a critical process that involves the creation, approval, storage, and maintenance of various types of artwork and documentation related to pharmaceutical products. These artworks typically include labels, packaging designs, package inserts, and other printed materials associated with pharmaceutical products. Effective artwork management is essential to ensure compliance with regulatory requirements, maintain product integrity, and streamline the production and distribution processes.
- Regulatory Compliance
- Artwork Creation and Design:
- Artwork Approval Process and Version Control
- Proofing and Validation
- Artwork Lifecycle Management and Vendor Management
Change control management:-
Change control management in the pharmaceutical industry is a critical process designed to ensure the safety, quality, and compliance of pharmaceutical products. This process involves identifying, evaluating, and implementing changes to various aspects of pharmaceutical operations, including manufacturing processes, equipment, facilities, documentation, and more
1.Evaluate and Audit Change controls, CAPA and Deviations
Impact Analysis: The change control team analyzes how the proposed change may impact product quality, safety, efficacy, and regulatory compliance. This involves a detailed assessment of potential consequences and necessary mitigation strategies.
Regulatory Compliance: In the pharmaceutical industry, adherence to regulatory requirements is paramount. Change control management ensures that all proposed changes comply with local and international regulations, such as Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP).
Documentation: Comprehensive documentation is essential throughout the change control process. This includes documenting the change request, evaluations, risk assessments, impact analyses, and any decisions made during the process. All documentation should be maintained in a controlled environment.
Regulatory Audits: We provide audit supports for different regulatory agencies worldwide(i.e. USFDA, MHRA, EMA, TGA, Health canada, Bfarm Germany and ROW)
GMP Compliance:-
Odi regulatory is committed to providing high-quality regulatory services for various pharmaceutical and biological products across the globe.
Odi reg spec
Artwork Management-
Artwork management in the pharmaceutical industry is a critical process that involves the creation, approval, storage, and maintenance of various types of artwork and documentation related to pharmaceutical products. These artworks typically include labels, packaging designs, package inserts, and other printed materials associated with pharmaceutical products. Effective artwork management is essential to ensure compliance with regulatory requirements, maintain product integrity, and streamline the production and distribution processes.
- Regulatory Compliance
- Artwork Creation and Design:
- Artwork Approval Process and Version Control
- Proofing and Validation
- Artwork Lifecycle Management and Vendor Management
Change control management:-
Change control management in the pharmaceutical industry is a critical process designed to ensure the safety, quality, and compliance of pharmaceutical products. This process involves identifying, evaluating, and implementing changes to various aspects of pharmaceutical operations, including manufacturing processes, equipment, facilities, documentation, and more
1.Evaluate and Audit Change controls, CAPA and Deviations
Impact Analysis: The change control team analyzes how the proposed change may impact product quality, safety, efficacy, and regulatory compliance. This involves a detailed assessment of potential consequences and necessary mitigation strategies.
Regulatory Compliance: In the pharmaceutical industry, adherence to regulatory requirements is paramount. Change control management ensures that all proposed changes comply with local and international regulations, such as Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP).
Documentation: Comprehensive documentation is essential throughout the change control process. This includes documenting the change request, evaluations, risk assessments, impact analyses, and any decisions made during the process. All documentation should be maintained in a controlled environment.
Regulatory Audits: We provide audit supports for different regulatory agencies worldwide(i.e. USFDA, MHRA, EMA, TGA, Health canada, Bfarm Germany and ROW)
GMP Compliance :-
Odi regulatory committs to provide high quality regulatory services for various pharmaceutical and biological product across the globe.
Odi reg spec
Meet Our Lead Instructors
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Chris Parker
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