Labela Regsources Private Limited

Mulund, Mumbai, Maharashtra
GST- 27AABCL9811A1ZT
Manufacturer, Service Provider
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  • Legal Status of Firm

    Limited Company (Ltd./Pvt.Ltd.)

  • Year of Establishment

    1997

  • Annual Turnover

    Rs. 50 Lakh - 1 Crore

  • Indiamart Member Since

    Dec 2010

Dossier Services

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Compilation of dossier as per latest country specific guidelines.
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
* Dossier compilation in Common Technical Dossier (CTD) format for : * Commonwealth of Independent States (CIS) Guidelines.

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Dossier Services

Product Details

Company Details

Product Description

Compilation of dossier as per latest country specific guidelines.
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
  • Dossier compilation in Common Technical Dossier (CTD) format for :
  • Commonwealth of Independent States (CIS) Guidelines.
  • South East / West Europe Guidelines.
  • Drafts data for :
  • BMR, MFR
  • Process Validation,
  • Analytical Validation,
  • Stability Study reports,
  • Dissolution profile,
  • Certificate of analysis and related reports
  • Reports on :
  • Bioavailability / Bioequivalance Studies,
  • Clinical Trials studies
  • Justification for fixed dose combination
  • Prepare Periodic Safety Update report (PSUR)
  • Preclinical studies like Toxicity, Carcinogenicity, Teratology and Reproduction toxicity.

Prepare Summary of product (SPC), Pack Insert, Product Rationale :

  • Expert Reports :
  • Quality,
  • Pre-clinical,
  • Clinical

Overviews (Module 2) :

  • Clinical
  • Non-Clinical

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About the Company

Year of Establishment1997
Legal Status of FirmLimited Company (Ltd./Pvt.Ltd.)
Nature of BusinessManufacturer, Service Provider
Annual TurnoverRs. 50 Lakh - 1 Crore
IndiaMART Member SinceDec 2010
GST27AABCL9811A1ZT
Headquartered in Mumbai, India, Labela Regsources, is a provider of complete solution on Regulatory Affairs to Pharmaceutical companies wanting to introduce products into global markets. Established in 1997, the company is headed by Rita Gada, a pharmacist with over 19 years of experience in the field of Global Regulatory Affairs. The team at Labela consists of well qualified and dedicated staff with rich experience of dossier compilation and regulatory filings across global drug authorities.

Labela strives to develop long-term relationships with clients, based on the highest levels of integrity, professionalism and trust. We are committed to doing business in an ethical and socially responsible manner.

Our Mission

Achieving beyond imagination with commitment to quality. We keep up high quality standards by continuous improvement in all operations through appropriate training, constant reviews, participation in seminars and conferences.

Our Vision

We strive to improve customer confidence in us, by way of constant interaction and feedback. Our goal is to foster long-term business alliances that promote growth and success for all concerned.

Our values

Respect for life of living beings, environment and law of the land. Innovation and excellence in our business processes. Satisfaction of customers and employees. Honest citizens committed to ethical business practices.
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Seller Contact Details

Labela Regsources Private Limited
Manager

Gala No. 1, Unique Industrial Estate, Opposite Jawahar Talkies, Dr. R. P. Road, Mulund, Mulund Mumbai - 400080, Maharashtra, India

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