Services.
1
Product Development and Dossier Preparation
Actively operating in this segment, we provide complete solution starting from Development to Approval.
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Preparation / Review of Validation Protocols
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Dossier Preparation, Dossier Review - Gap Identification
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Submission with Regulatory Authorities
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Post Submission Support / Handling of Queries
2
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.
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3
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.
eCTD Job with VR.
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.
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.
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.