International Trade & Business Development Group
Your partners in global success

How can we help your business

Our services include marketing & distribution solutions, export/import solutions, pharmaceutical regulatory solutions and more. Our services are comprehensive and confidential.

Our business segments include ITBD Business consulting, ITBD Trade (export-import) consulting, ITBD Franchise consulting, ITBD Investment consulting and ITBD Pharmaceutical consulting includes Pharmaceutical Marketing. Pharmaceutical Regulatory, Pharmaceutical / Biopharmaceutical Design, Enginearing & constructions consultancy.

ITBD Pharmaceutical consulting is a key area of specialization that assists pharmaceutical companies from Bangladesh & other developing countries to connect with other pharmaceutical and biotechnological companies and importers / exporters in key markets, and directs the complete implementation process of opening and managing operations in the U.S.A. & Canada, Europe, and other locations. We also provide regulatory consultancy for U.S. FDA & Health Canada though our partner consultants.

Our Regulatory Consultancy and Pharmalicensing Intelligence includes consultancy for U.S. FDA Drug and plant approval process, consultancy for the Health Canada drug approval process, consultancy for EMEA drug approval process, and consultancy for Gulf Central Committee for Drug Registration (GCC-DR).

 

ITBD Business & Trade Consulting are the strategic business units of ITBD Group that assist clients globally to enter, evolve and expand in emerging and developed markets through fact-based market analysis. The areas of specialization include market opportunity assessment, competitive analysis, new product development, distribution channel and value chain analysis, market entry strategy and partner diligence.

ITBD Franchise consulting helps branded franchises from developed country to enter in new markets like Bangladesh and others.

ITBD Investment consulting assists partners select and invest in projects offering positive return in a variety of industries and regions.

Our consultancy for U.S. FDA drug approval assists our clients to obtain and maintain FDA approvals. Our expert partners have worked over 35 years on new drugs, generic drugs, over the counter drugs, and DESI drugs.

We have succeeded in every drug therapeutic category because we know the FDA drug approval process ‘inside out’. We know what is needed because we have compiled successful documentation in all these areas :

  • GMP/GCP/GLP Compliance
  • SOP Writing
  • Toxicology
  • Formulation
  • Pre-Ind Meetings
  • Validation
  • Electronic Submissions
  • FDA Drug Recall
  • FDA Consultant-Audit Inspections and Operations
  • IND
  • NDA
  • ANDA
  • BLA

Our assistance with the Health Canada Drug Approval Process includes working with Natural Health Products, including:

  • Site Licence Application

  • Set up of quality system (Good Manufacturing Practices)

  • Product Licence Application

  • Answer to Information Request Notice from Health Canada

  • Audits of suppliers

And drugs, including:

  • DIN Applications

  • Quality Assurance Services

  • GMP Audits

Why not call us now at 1-647-707-36291-647-707-3629 or email to info@itbdg.com