Extensive experience in Operations, Supply, Manufacturing, Quality and Regulatory Compliance, with strong network connections, successful projects and expertise in Operations Excellence, Plant management and performance improvements, DFA proudly delivered great services and became the provider of choice to several clients, achieving their strategic goals.
We are consulting to BARDA/HHS in the former Operation Warp Speed supporting the development, manufacturing and distribution of Covid-19 through the USA.
DFA also partners with PGI PHARMA and 4TUNE Engineering, providing a wider range of services, including the SIMULA PHARMA System www.pgifarma.com.br).
DFA is a specialized consulting company, USA based with a subsidiary in Brazil, working with extensive experienced partners from top Pharma and Biotech companies and premier advisory firms, all with significant and successful careers in their areas of expertise. We have particular focus and success in facilitating companies investing in new business, operations expansions or process improvements, due diligences, products supply chain and logistics, regulatory compliance, acquisitions or licensing, including accessing broader territories, especially the emerging markets. Our expertise can support business in several countries through our network in the United States, Europe, Asia and Latin America, coupled with established proficiency in the areas of Business Development, Manufacturing, Licensing, Supply Chain, Quality, Regulatory Affairs as well management support to turn around business/operations results and to unlock potential growth through Business and Operational Excellence / Lean 6 Sigma initiatives.
We offer strong partnerships such as Dynami Pharma LLC, MedicaRx, PGI Pharma and 4Tune Engineering, adding a wider range of services, among them the unique SIMULA PHARMA System (see it at www.PGIfarma.com.br).
People make the difference. We will help them make it happen.
BUSINESS AND PRODUCT DEVELOPMENT
Our services focus on our clients' critical needs, strategic actions towards faster growth and opportunities to increase market share, including acquisitions and expansions (manufacturing footprint or to other territories), licensing in/out, partnership/JV agreements, market penetration or expansions into new areas and business niches.
We have numerous worth of worldwide transaction experience in Business Development, Startup fund raising through facilitating their connection with foreign and domestic investors, association for expediting and funding clinical trials, manufacturing footprint, regulatory compliance with different agencies, licensing deals and internationalization of their business strategies.
Our Product Development partners and specialists are connected to high level scientists and technical services group capable of innovating through formulation problem solving, changes, introduction of new pharmaceutical forms, solving complex formulation issues or any technical transfer/improvement needs.
DUE DILIGENCES / ACQUISITIONS
Our specialized and experienced teams developed broad know-how and tools that allow performing Due Diligences in a very efficient timeline, evaluating assets, covering all Operations, Quality, Regulatory, Supply Chain, Logistics, overall Organization and people assessment, procedures and systems for best advisement on decision making for an acquisition, expansion, establishing new manufacturing plants, being green field or adaptation of existing plants, or new partnership deals.
Our multi national and multi cultural experience allow and facilitate companies to enter and negotiate deals across the world, import/export products, better understand specific and critical differences in business practices with very special contacts with Regulatory agencies such as FDA, Anvisa and other Government departments in Latin America.
With first-hand insight of key industry trends and opportunities, we love what we do and we love bringing our success to our clients.
OPERATIONS EXCELLENCE, PERFORMANCE IMPROVEMENT
DFA consultants have large experience acting as Operations change agents, providing expertise in supporting companies to reach significant improvements in performance through Operations Excellence, Change Management, Lean Six Sigma, cultural transformation aiming a high performance organization. Our approach to cultural and performance improvement includes:
▪Integrated production value stream introducing new processes and projects, connecting departments and support functions, establishing good business processes.
▪Customer setting the pace of Manufacturing and Supply Chain planning.
Use of tools such as Simula Pharma system to simulate changes and immediately visualize impacts through out the company.
▪Cost and Process optimization and higher competitive performance and results
▪Everyone engaged in improving performance (kaizens) as part of day to day job, highly motivated well trained operational teams
▪Leaders are focused on stabilizing the shop floor and acting as coaches allowing good ideas to emerge
Even well managed companies use only a small piece of its creative and productive potential. We partner with the leadership team, supporting them step out of their day to day pressure to be able to see the bigger picture, identify opportunities and improve their management skills and operational results. Our process connects tools, methods, systems, mindsets and behaviors towards better results.
DFA Consulting LLC partners with Dynami-Pharma (www.dynami-pharma.com) and most recently established a partnership with PGI Pharma (www.PGIfarma.com.br)who developed the SIMULA PHARMA system, a very unique tool that allows simulations on any and all changes in processes, equipment, labor, investments, performance etc. visualizing immediately all financial impacts in your company, up to the Unit Cost per product. Along with PGI Pharma, we bring 4Tune Engineering, with vast knowledge and experience in providing solutions for clients globally, be ready for Industry 4.0.
Our insights have been formed through decades of running networks of plants and organizations and via interactions with regulatory agencies, governments, investors and market innovators.
A Tool that allows a revolution in the performance and decision making in your company.
- Simulate any changes, among them: process, products, capacity utilization, technology etc. and visualize immediately the financial impacts, unit costs and opportunities or wastes you have.
- Develop a Strategic Plan or Investment plans based on accurate simulations and their financial impacts at the product by product unit cost level.