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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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| Bioavailability / Bioequivalence / Clinical Trial Studies (BA / BE / CTR) |
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 We also have active association with approved study centers with state of art facilities to perform BA/BE studies (single dose, multiple dose, 2-way, 3-way, replicate design & dose proportionality studies, immediate and modified release, various dosage forms of known molecules) as well as Phase I, II, & III clinical studies.
Bioequivalence studies is a science based regulatory affairs project which includes a combination of studies based on specialization. The main aim is to establish if rate and extent of absorption of the given sample of the drug is comparable with innovators formulation.
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| Our Strengths |
| Tie Up with well established study centers to carry out BA / BE / Clinical Studies. |
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| We add value by |
| Helping clients carry out BA/BE studies in well established study centers, which are approved from local DCGI and international WHO, EU, US FDA, Geneva, TGA – Australia, Medsafe – New Zealand and Brazil – ANVISA. |
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| BA/BE Studies Conducted |
Conducted more than 200 Studies for Semi Regulated Market like CIS Countries, Russia, Latin America, African countries, Middle East countries etc.
Conducted over 5 studies for highly regulated market like Europe, TGA-Australia, South Africa, Brazil Anvisa. |
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| Format And Guideline:- As per country specific guideline. |
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