ITBD Group provide following services for Pharmaceutical Company:
1. Build a new plant (Pharmaceutical, Biotechnological & API) with construction and engineering consultancy
2. Facility design
3. Set up of Quality Systems
4. Product selection for regulated market (USA, Canada, UK, European countries, South American Countries & others)
5. Product development
6. Qualification and validation
7.
Regulatory submission for US FDA, UK MHRA, EMEA and Health Canada:
Organizing and coordinating the material, reviewing, compiling and
submission
8. Pre-approval inspection, US FDA & other regulatory bodies
9. Post approval activities
10. API Plant set up and other consultancy
11. Bioequivalence testing, laboratory set up and other consultancy
12.
If your company files an ANDA, you will need to assign a US FDA
Regulatory agent, we can provide that service for your company
13.
Commercialization of pharmaceutical product in regulatory market:
Through our network of 5,000 companies in 150 countries; we can help to
find client company, marketing partners and importer in most countries
like USA, Canada, United Kingdom, European countries, Latin American
countries and others
14. Importing biotechnological and high tech products in Bangladesh:
We
assist in dealing with local companies and foreign Biotechnological
Companies and R&D-based Pharmaceutical Companies from the USA,
United Kingdom and other European countries
15.
Training: Offering training for business development, marketing,
presentation skills, strategic planning skills, report writing skills,
international supply chain and product development, documentation, GMP
training and FDA regulatory training
16. Arrange contract manufacturing from USA, UK and European countries
17. API & all raw material sourcing from highly regulated market
18. Pharmaceutical software and consultancy