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Regulatory Affairs.

We provide artworks and Inserts  compliant with one or the other as per the regulatory requirements, In many cases, this leads to increased cost of inventory destruction and regulatory compliance with the authority, and multiple change controls / processes internally leading to poor efficiency.

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We have a dedicated team of publishing/submission experts supported by senior regulatory leaders.

eCTD publishing of all submissions or as an eCTD publishing back-up for any urgent sequences required, lifecycle management, validation for all published sequences, submission to the relevant health authorities.

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CTD & eCTD Job with VR.

CTD

The CTD is organized into five modules: 

 

  • Module 1: Administrative Information (region-specific). 

  • Module 2: Summaries (Quality, Nonclinical, Clinical). 

  • Module 3: Quality (information on manufacturing and control of the drug product). 

  • Module 4: Nonclinical Study Reports (data from non-human studies, like animal testing). 

  • Module 5: Clinical Study Reports (data from human clinical trials). 

ACTD

The ACTD organized into four sections: 

  • Part I: Administrative data and product information.

  • Part II: Quality-related documents.

  • Part III: Non-clinical data.

  • Part IV: Clinical data. 

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ASEAN member states, including Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Viet Nam.

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eCTD

Since our inception, Zenith Consultancy team has been totally focused on building a strategic, quality search practice. Our team is expert in eCTD file preparation for GCC- Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates. Giving strategic and technical advice at the highest level. More than 10 experts are associated with us.

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We have a dedicated team of publishing/submission experts supported by senior regulatory leaders.

eCTD publishing of all submissions or as an eCTD publishing back-up for any urgent sequences required, lifecycle management, validation for all published sequences, submission to the relevant health authorities.

 

Conversion of NeeS or paper dossiers to eCTD for Baseline submissions, We outline company strategy to implement a standard structure, format and granularity of eCTD dossiers submitted


Drug Master Files
eCTD Publishing
eCTD Submission
eCTD Lifecycle submission management

Writing/Review/Filing of Submissions ( CTD/ACTD and Semi-Regulated Countries)

Product Monograph and Mock-up development as per Plain Language Labelling (PLL), SmPC writing

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MS Word Formatting 

Any document that is being prepared for eCTD submission must be formatted correctly. Ensuring margins, font sizes, cross referencing, tables are present. Without a pre-defined Word template to work from, this can be a very time-consuming task. At Zenith Consultancy, we have years of experience formatting MS Word documents for eCTD submission.

eCTD MS Word & PDF Formatting

When publishing PDF files, it is important to consider the MS Word and PDF specifications guidance. These best practices come from recommendations from the ICH, We take great care of guidance on PDF specifications when publishing PDF files, in order to meet the maximum efficiency for every submission.

PDF Publisheing

We take great care to follow industry guidance on PDF specifications when publishing PDF files, in order to meet the maximum efficiency for every submission. These best practices come from recommendations by the ICH and regional regulatory authority, and are essential for a successful submission that avoids technical rejection. By adhering to these standards, we can ensure that our PDF files meet the highest quality standards.

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GAP Analysis

We offer a comprehensive assessment of our clients’ documents and current processes to ensure they are aligned with the eCTD requirements of regulatory authorities. We provide guidance on how to create eCTD compliant documents. This allows our clients to stay compliant with the latest regulatory requirements and improve their overall efficiency.

eCTD Submissions Management Services

Regulatory submission management can be a complex process, we manage the complex and make it simple. We wholly manage the eCTD process, from start to finish, maintaining a complete overview of the submission across multiple lifecycle stages and to global regulatory health authorities.

Product Life Cycle Management

MA applications and License Holding is one part of the complete process. Once MA is obtained, each product needs continuous monitoring to ensure that commercial batches are in line and compliant with the regulations. Even a small Change Control, without effective impact assessment can lead to suspension of registration or an import alert for the complete manufacturing site.We handle the complete product life cycle, starting from receipt of MA, Variation and Compliance Applications, up to filing of Renewal and receipt of Renewals.​

Product Development and Dossier Preparation

Actively operating in this segment, we provide complete solution starting from Development to Approval.

  • Preparation / Review of Validation Protocols

  • Dossier Preparation, Dossier Review - Gap Identification

  • Submission with Regulatory Authorities

  • Post Submission Support / Handling of Queries

Package Insert (PIL / SmPC) & Artworks / Pack Management

We provide artworks and Inserts  compliant with one or the other as per the regulatory requirements, In many cases, this leads to increased cost of inventory destruction and regulatory compliance with the authority, and multiple change controls / processes internally leading to poor efficiency.

Contact us

Need more details? Contact us

We are here to assist. Contact us by phone, email or via our social media channels.

Call us: +91-8950072720

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