Pharma Consultancy
ITBD Group provides regulatory consultancy for the U.S. FDA Drug and plant approval process; the Health Canada drug approval process; UK MHRA, EMEA drug approval and Gulf Central Committee for Drug Registration (GCC-DR).
In addition the ITBD Group provides following services to pharmaceutical companies:
- Building a new plant (Pharmaceutical, Biotechnological & API) with construction and engineering consultancy
- Facility design
- Putting in place a robust Quality Assurance System
- Product selection for regulated market (USA, Canada,
UK, European countries, South American Countries & others)
- Product development
- Qualification and validation
- Regulatory submission for US FDA, UK MHRA, EMEA and Health Canada; Organizing and co-ordinating the material, reviewing, compiling and submission
- Pre-approval inspection by US FDA and other regulatory bodies
- Post-approval activities
- API plant set-up
- Assistance in bioequivalence testing, laboratory set-up
- If your company files an ANDA, you will need to assign a US FDA Regulatory agent. We can provide that service to your company
- Commercialization of pharmaceutical products in regulated market
- Importing biotechnological and hi-tech p roducts in emerging markets
- Training for business development, marketing, strategic planning, report writing, supply chain management, product development, documentation, GMP training and FDA regulatory training
- Arranging contract manufacturing from USA, UK and some European countries
- API & all raw materials sourcing from highly regulated markets
- Providing pharmaceutical software consultancy
International Business Consultancy
- What are the best export markets for my product and service?
- What could be the best entry strategy for these markets?
- How do I navigate their complex trade processes?
- Is my company compliant with export/import rules and regulations applicable in those countries?
- How do I leverage international expansion for my company’s long-term growth?
At ITBD Group, we can help you address those vexing questions. Our portfolio of services includes personalized assistance, from the first approach to a new market up to the formulation and execution of a slew of marketing strategies for business expansion and development, after you have made a successful entry.
The ITBD Group provides customized consulting and support services to help companies to launch, expand, and succeed in other countries. We offer a uniquely comprehensive suite of services that no other firm can match, and we tailor those services to each client’s unique business needs. Our international consulting team is highly experienced in:
- Market research analysis
- Trade mission Organization
- Public consultations
- Strategic planning; and
- Practical, results-orientated business planning
Our Strategic Business Units
The ITBD’s SBUs include:
Pharmaceutical Consulting
This is ITBD Group is key consulting practice that has special interest in assisting pharmaceutical companies from emerging market and other developing countries to connect with their counterparts in mature markets.
Our areas of specialization in this field include market opportunity assessment, competitive analysis, new product development, distribution channel and value chain analysis, market entry strategy, partner diligence, SOP writing, filing DIN Applications, providing Quality Assurance Services and GMP Audits.
Pharmaceutical Regulatory Consultancy
The FDA approval process is a complex process, but The ITBD Group consultants are armed with the deep domain knowledge, understanding and over two decades of experience to make this process work for your project and get you the much-coveted approval for your pharma product. The ITBD Group’s team of highly experienced experts has expert knowledge of all the rules and regulations governing: import norms, export, labeling practices, approval protocols, shipping and post-marketing requirements for foreign entities. Our strong track record testifies to the quality results that we have delivered to our large and small clients, across the world.
Pharmaceutical Designing, Engineering and Validation Consultancy
We provide architectural and engineering services to the Pharmaceutical, Food, Beverage, Cosmetic and Fin e Chemicals Industry. Our scope of services covers concept design to detailed engineering, commissioning and start–up for these industries. We have experience of designing and engineering of various facilities required in pharmaceutical Industry such as:
- Dosage form Manufacturing Facility for both OSD and Aseptic Products
- API Manufacturing Facilities
- Pilot Plants for Dosage Forms
- Active Pharmaceutical Ingredient (API) Pilot Plant / Kilo Labs
- Analytical Laboratories
- Research and Development Laboratories
We have several years of experience in designing Laboratories, API and Formulation Facilities for Cytotoxic Compounds, Hormones and Steroids.
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