We are experts at formulation development, analytical method development, manufacturing process development and tech transfer, CRO management for BE studies, CMC regulatory documentation, and regulatory filings.
ABOUT VICI HEALTH SCIENCES
Vici was founded by Dr. Anish Dhanarajan, PhD and Francesca Minale, M.Eng in 2016 with the goal of becoming a world class pharmaceutical product development company. Vici works hard at identifying unmet pharmaceutical needs that can be solved by drug development through the NDA 505(b)(2) or ANDA pathway. In pursuit of this goal, Vici operates a rapid, low-cost, high quality prototyping R&D facility capable of GMP operations in Maryland, USA.
Working with CROs, third party testing labs, experienced consultants, manufacturing plants, and marketing partners, Vici is able to deliver and manage entire development programs. Vici engages in product out-licensing and contract development.
We believe in building long term, lasting relationships with our customers, and each employee is committed to providing quality and transparent information to promote growth and understanding.
Each employee is committed to producing safe and effective products, along with providing reliable information and service to customers.
dr. Anish Dhanarajan
Anish Dhanarajan oversees all operations within Vici, from product selection through FDA filing and approval. Anish is a passionate scientist who uses his expertise in research and development to select and execute projects that create value for all stakeholders.
Anish managed formulation development at companies such as Pfizer, GSK, Mallinckrodt, and CorePharma prior to founding Vici. Anish is an expert in solid and liquid oral product development and manufacturing processes.
Anish graduated from Anna University with a Bachelors of Science degree in Biotechnology. He went on to complete his Ph.D. in Biomedical Engineering/Chemical Engineering at the University of Minnesota.
Francesca Minale, m.eng.
Francesca Minale manages all of Vici’s regulatory work, including p-INDs, INDs, and ANDA filings. Francesca also oversees the QA department to ensure GMP compliance is maintained.
Francesca worked as a formulation development scientist and manager at CorePharma and Wes Pharma prior to the founding of Vici Health Sciences. Francesca is well versed in formulation, quality, and FDA regulatory requirements, and brings a high-energy creative dynamic to the work-place.
Francesca graduated with a Bachelor’s in Biological/Biosystems Engineering and a Master’s in Biomedical Engineering from Cornell University.
Dr. Bireswar Chakraborty
Sr. Director, Formulation R&D
Bireswar Chakraborty leads the Vici formulation department through all stages of product development, manufacturing, and tech-transfer.
Bireswar is a pharmaceutical and biotech product development and manufacturing expert with over twenty-five years of experience in complex injectable, ophthalmic, nasal/inhalant, and topical pre-formulation, formulation development, tech-transfer and manufacturing, and regulatory filing.
Bireswar obtained his Bachelor’s and Master’s in Pharmacy from Jadavpur University. He went on to obtain his Ph.D. in Pharmaceutical Chemistry from the Massachusetts College of Pharmacy.
What are Vici’s core capabilities?
Vici excels at oral and injectable formulation and analytical method development. We are experts at rapidly formulating simple or complex oral tablets, capsules, solutions, and suspensions. We are also able to formulate potent compound injectable solutions and suspensions in vials and ampoules and can work with complex API, including peptides. We develop formulations that are stable and have required bioavailability/bioequivalence to a reference product, meet FDA guidelines and can be easily and reliably manufactured.
What is Vici’s business model? How do we work with Vici?
(a) Vici develops products for our customers under a fee-for-service contract, or (b) Vici out-licenses products to our customers who wish to own and commercialize the asset. We want to use our core expertise to help grow your revenue and are willing to work under any model that is mutually beneficial. Please contact us to discuss how we may engage together in product development and commercialization.
What is the full range of services offered by Vici?
At Vici we can perform and manage all aspects of product development. For example, we’re perfect partners for commercial focused company that don’t have in-house product development capabilities or know-how. Starting from product selection through FDA filing and approval, we can do it all.
What does Vici have in-house and what can Vici manage through third party providers?
Vici can perform formulation and method development through pilot/phase I clinical batch manufacturing in-house at our Maryland facility. Subsequent steps, such as clinical studies, tech transfer, registration batch manufacturing and FDA filings are managed through working with preferred third-party service providers with whom we have established partnerships. We can oversee and manage all such activities to ensure timely and high-quality outcomes.
Is Vici a GMP facility?
We are an R&D facility that also operates under cGMP for pilot/phase 1 clinical supplies manufacturing. Our analytical lab operates following all GLP guidelines.
Can Vici manufacture clinical trial material?
Vici can manufacture and release-test pilot and phase 1 clinical trial material.
Can Vici handle DEA controlled substances?
Yes, Vici can handle DEA schedule II-V controlled substance material.
Can Vici perform solvent processing?
Vici can perform solvent processing such as fluid bed coating and pan coating.
How is Vici different from other companies that develop pharmaceutical products?
We are a small US-based pharmaceutical development company that is founder-run. At Vici, we aim to delight our clients and partners through speed, flexibility, high quality, transparency, and communication. You can call or text the company owners, who are also the technical managers, with your concerns and expect an immediate response and resolution to your problems. You can drop-in our site with a day’s notice and expect to be able to review operations. This level of service at a very reasonable cost in the US is unique to Vici.