A few things we’re great at
End to end Regulatory Affairs, End to end Labeling service, End to end Regulatory Operations, Quality & GMP services
Regulatory Affairs
End to end Regulatory Affairs services (dossier submissions (pre approval and post approval), product launch activity, and life-cycle management, compliance and audit support, and regulatory strategy) to pharma and healthcare industry globally
Regulatory Labelling
End to end Labeling service (Structured product labeling SPLR4 i.e. Establishment Registration, NDC Labeler Code Request, GDUFA Self Identification Request, Drug Listing for PLR and Non-PLR, Artwork Management, Labeling components preparation)
Regulatory Operations
nd to end Regulatory Operations services (publishing and submission, document level publishing, submission level publishing, submission management, submission gateway assistance) to pharma and healthcare industry throughout the globe
Quality/GMP Audit
Quality & GMP services in compliance with current Industry & Global Health Authorities standards to Pharmaceuticals, Biopharmaceutical, Life-sciences, CDMO industries (Formulation and API).
CASE STUDY
The Secret of Success
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CASE STUDY
The Secret of Success
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Trials
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Regulatory
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Investigations
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Statistics
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Client Testimonials
Don’t take our word for it – here’s what our clients say:
Do you sometimes have the feeling that you’re running into the same obstacles over and over again? Many of my conflicts have the same feel to them, like “Hey, I think I’ve been here before,
John Doe
Company name
Do you sometimes have the feeling that you’re running into the same obstacles over and over again? Many of my conflicts have the same feel to them, like “Hey, I think I’ve been here before,
John Doe
Company name
Do you sometimes have the feeling that you’re running into the same obstacles over and over again? Many of my conflicts have the same feel to them, like “Hey, I think I’ve been here before,
John Doe
Company name
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Our Team
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Latest News
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eCTD Global provides Regulatory Operations / Publishing support.
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