Our Services
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What We Provide Best
With 35+years of rich experience as a CONSULTANT, AUDITORS & TRAINERS into Medical Devices, Pharma, Biotech, & Nutraceutical Industries, we aim to deliver
- Commitments to the clients,
- Focusing on transparency,
- High quality standards
- Explore an alliance to get faster approvals across the Globe along with start to end services.
We are based at Thane-Mumbai and providing services across the Globe [USA, EUROPE, CANADA, BRAZIL, ASEAN, BANGLADESH, MENA, GCC, ROW & ACROSS PAN INDIA]
What We Offer
Clinical Trial Clinical Study
Common Technical Document
What We Offer
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Regulatory Services
Regulatory approvals are mandatory to legally sell. Given the complex..
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Compliances
Regulatory Compilation of all modules CTD-M1, M2, M3, M4, M5 and Global ...
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Audits
Audits & Pre-Approval Inspection as per country-specific requirements...
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Quality Systems
We provide made to measure quality system solutions that are...
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Labelling Management
Labelling is an important aspect of the marketing of a product. Regulatory...
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Documentation
Dossier writing from Module 1 to Module 5 for generic and new drug...
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Product Management
Product Life cycle Management i.e., Product variation / amendment...
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Validation
We provide made to measure quality system solutions that are tailored...
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Training
In House Training and Workshops into RA, QA, GMP, ICH, QbD, Clinical Research, PV...
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Clinical Trial Clinical Study
Clinical validation is one of the most important and critical aspects of...
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Common Technical Document
MAA CTD for Europe Submission, South Africa-CTD, Australia-CTD...