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The One Stop For all Your Regulatory Requirements
 
We Provide Free Consultation For Pre-product Registration / Pre- pharmaceutical Dossier Preparation Inquiries. We take a Multi-Faceted Approach to Medical Device Distribution Management.

Services / Our expertise:

Technical Reach

Dosage Form

Therapeutic Areas

Medical Devices

Bioavailability / Bioequivalence / Clinical Trial Studies (BA/BE/CTR)

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 (CTR).

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.

Our Strengths
Tie Up with well established study centers to carry out BA/BE/Clinical Studies.

We add value by
Helping clients carry out BA/BE/CTR 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.

Format And Guideline:- As per country specific guideline.
 
 
 
Dossier compilation as per:
> Asean Common Technical    Dossier (ACTD) Guidelines
> South Africa (MCC-MRF-1)    Guidelines.
> Brazil ANVISA Guidelines
 
Dossiers compilation for submissions in:
> Asia
  
> Africa  
> Central  America  
> South  America  
> North  America  
> CIS countries
 
 
Dossier compilation in CTD format for:
> South East Europe
> South west Europe
 
 
Drug master file (DMF) compilation for open and closed parts
 
 
  Our area of expertise
 
Data base of regulatory requirements of more than 100 countries & for more than 5000 molecules. Speedy compilation of Dossiers for Regulated and Semi Regulated markets.

 *  Regulatory submissions, Liaison with Regulatory       boards and follow-ups.

*    Complete regulatory support till the registration       stage.

*    Reports on Bioavailability / Bioequivalance Studies,       Clinical Trials studies boards and follow-ups.

*    Draft data for Process Validation, Analytical
   Validation, Stability Studies report, Dissolution       profile, Certificate of analysis and related reports.

*   Prepare Periodic Safety Update report (PSUR) to      fulfill CIS registration dossier requirements.

*   Prepare Summary of product (SPC), Pack Insert,      Product rationale to fulfill registration dossier      requirements.

*   Expert Reports – Quality, Pre-clinical, Clinical to fulfill      CTD registration dossier requirements.

*   Overviews - Clinical / Non-Clinical to fulfill CTD      registration dossier requirements.

*   Liaison for Process Validation, Analytical Validation,      Stability Studies and related reports.

*   Reports on Preclinical studies like Toxicity,      Carcinogenicity, Teratology  and Reproduction      toxicity.

*   Liaison for Bioavailability / Bioequivalance Studies,      Clinical trials report and related reports for CTD,      Geneva, TGA – Australia, Medsafe –  New Zealand      and Brazil – ANVISA .

*    Dossier conversion (from one country to another)

*    Registration Assistance.

*    Drug master file (DMF) compilation for open and       closed parts.
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