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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

Analytical Solutions

Analytical Solutions is a contract analytical laboratory that provides quality, timely and cost-efficient analytical services to the pharmaceutical.

We have tie-ups with well established FDA approved lab to carry out analytical testing like : -

  • Product performance testing (including dissolution, release rate and content uniformity),
  • Release testing for Active Pharmaceutical Ingredients (APIs) and formulated drug products,
  • Process Validation,
  • Analytical Validation,
  • Stability data studies,
  • Analytical Report,
  • Impurity profile,
  • Related substances report,
  • Dissolution profile etc.

(All the data supported by necessary Chromatograms & Spectrums).
 
 
 
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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