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Compilation of dossier as per latest country specific guidelines
Ω Dossier compilation as per :
• Asean Common Technical Dossier (ACTD) Guidelines.
• South Africa (MCC-MRF-1) Guidelines.
• Brazil ANVISA Guidelines.
Ω Dossiers compilation for submissions in :
• Asia
• Africa
• Central America
• South America
• North America
Ω Dossier compilation in Common Technical Dossier (CTD) format for
• Commonwealth of Independent States
(CIS) Guidelines.
• South East / West Europe Guidelines.
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Ω Drug master file (DMF) compilation for open and closed parts
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Ω Drafts data for
• BMR, MFR
• Process Validation,
• Stability Study reports,
• Dissolution profile,
• Certificate of analysis and related reports
Ω Reports on
• Bioavailability / Bioequivalance Studies,
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Clinical Trials studies
• Justification for fixed dose combination
• Prepare Periodic Safety Update report (PSUR).
• Preclinical studies like Toxicity, Carcinogenicity, Teratology & Reproduction toxicity.
Ω Prepare Summary of product (SPC), Pack Insert, Product rationale.
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Ø Expert Reports
• Quality,
• Pre-clinical,
• Clinical
Ø Overviews (Module 2)
• Clinical
• Non-Clinical
Ø Nonclinical Study Reports(Module 4)
Ø Clinical Study Reports(Module 5)
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Ω Ready dossiers available in ACTD, CTD, Asian, African, CIS, Central America, South America, North America.
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Ω Dossier conversion (from one country to another)
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Ω Registration Assistance
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Ω Labela Regsources has a specialized division that helps medical device manufacturers research, analyze, select & manage Indian medical device distributors.
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| Regulatory Submissions |
| We drive our business consultancy on various aspects related to product selection, fixing the price, Appointing importer, information on rules and regulations, market conditions, competition, product viability. We also offer our best services and supports for your business expansion to the following countries. |
Middle East - Vietnam,Cambodia, Mynamar, Phillipines, Thailand
African Countries - Kenya, Uganda, Tanzania
CIS Countries - Kyrgyzstan, Uzbekistan, Turkmenistan, Georgia, Tajikistan, Belarus, Kazakhstan, Azerbaijan, Ukraine, Russia. |
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| We undertake the full project i.e after careful market survey we select products of priority for registration and also provide complete regulatory support till the registration stage. |
> Company registration.
> In getting brand search and getting NOIP Acceptance from National Office of Intellectual Property.
> Preparation of medical dossiers for registration of medical products.
> Translation of medical dossiers into the local language before submission of documents to the Health Ministry for
product registration.
> Handling query if any on your behalf.
> Execution of registration process until the procurement of registration certificates. |
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| Render the following Services : |
> Asean Common Technical Dossier (ACTD) Guidelines
> South Africa (MCC-MRF-1) Guidelines
> Brazil ANVISA Guidelines |
| Dossier compilation in Common Technical
Dossier (CTD) format for : |
> Commonwealth of Independent States (CIS) Guidelines
> South East / West Europe Guidelines |
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| Dossiers compilation for submissions in : |
> Asia
> Africa
> Central America
> South America
> North America |
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