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Geetank Firm

Sector 5, Kurukshetra, Haryana

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VANANK REGPHARMA SOLUTIONS develops long-term relationship with clients, based on the highest levels of integrity, professionalism and trust.
VANANK REGPHARMA SOLUTIONS SOLUTIONS realizes success depend on customer satisfaction. Therefore, our purpose is to serve our customers and we shall provide guidance based on our skills and expertise.
VANANK REGPHARMA SOLUTIONS committed to doing business in an ethical and socially responsible manner.
We are a customer centric organization and our prime forte is to satisfy our global clients by offering them quality Dossiers, be it hormonal medicines, antibiotic medicines, gynaecological drugs or Veterinary drugs
We ceaselessly endeavor to achieve new clients besides maintaining good relation with the old ones.
Our diligent efforts have enabled us in garnering a broad client base all across the globe.
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Nature of Business

Consultants

Total Number of Employees

Upto 10 People

Year of Establishment

2013

Legal Status of Firm

Individual - Proprietor

Annual Turnover

Upto Rs. 50 Lakh

CTD Dossiers
  • CTD Dossiers
  • CTD Dossiers
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CTD Dossiers

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This is VANANK REGPHARMA SOLUTIONS The Common Technical Document (CTD) is a set of specification for application dossier, for the registration of Medicines and designed to be used across Europe, Japan and the United States. Quality, Safety and Efficacy information is assembled in a common format through CTD .The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
The Common Technical Document is divided into five modules :-

Module 1 : Administrative information and prescribing information
Module 1 : Administrative information and prescribing information
Module 2 : Common Technical Document Summaries (Overview and summary of modules 3 to 5)
Module 3 : Quality
Module 4 : Preclinical Study Reports
Module 5 : Clinical Study Reports (Clinical studies)

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ACTD Dossiers
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ACTD Dossiers

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The ASEAN (Association of Southeastern Asian Nations) have observed this and are now drafting the ASEAN CTD, a standard derived from the CTD. In place of the 5 modules, the ACTD organized the submission into 4 parts. This is done because ASEAN members usually only receive reference applications -- applications to put a drug on the local market that has already been approved elsewhere. As a result, the need for detailed documentation is lessened -- most study reports are not required to be submitted.
Module 1 in the CTD (the regional and registration information) is still present as Part I in the ACTD. ICH M2 is dropped and the summaries are absorbed into the subsequence parts. Quality information (ICH M3) is Part II of the ACTD, Nonclinical (ICH M4) is Part III, and Clinical (ICH M5) is Part IV.
Common Technical Document for ASEAN countries contains of four parts :-

Part I : Administrative information
Part II : Quality
Part III : Nonclinical Study Reports
Part IV : Clinical Study Reports

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Preclinical/Non-Clinical/Toxicological Studies
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Studies in which a drug is tested on animals and in other non-human test systems. The main goals of pre-clinical studies (also named animal toxicology and non-clinical studies) are to determine a product's ultimate safety profile. For instance, drugs may undergo pharmacodynamics (PD), pharmacokinetics (PK), ADME, and toxicity testing through animal testing.

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Bioavailability/Bioequivalence (Ba/Be) Studies
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Bioequivalence main aim is to establish if rate and extent of absorption of the given sample of the drug is comparable with the innovator's formulation.
VANANK REGPHARMA SOLUTIONS a also have active association with approved study centers with state of art facilities to perform BA/BE studies. BA/BE studies are carried out in accordance with current GCP as per the ICH guidelines.
Coordination for BE studies (on behalf of formulation manufacture)Low cost due to our long-term alliance with CROsProviding complete protocol, report and chromatogramsHandling all pre-registration and post-registration queriesBioequivalence studies format :- As per country specific guideline.

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