Contract Development
Being small and US-based, we are able to focus on speed, quality, responsiveness, and affordability. Talk to us about your product development needs today.
We have proven expertise in finding innovative, low-cost, high-quality solutions to technical and logistic problems and we pass the savings on to you. Being US-based, we are your ideal one-stop R&D partners. Being a small, flat organization, speed and attention to your project are guaranteed. We can manage all aspect of product development and work with local and international manufacturing partners to have your product concept developed, manufactured and FDA approved in record time.
SERVICES OFFERED
- Solid and liquid oral dose formulation development
- Injectable formulation development
- Ophthalmic formulations
- Complex formulations
- Extended release formulations
- Potent compound formulations
- Tablets, capsules, oral solutions and suspensions, ODT, extended release suspensions, chewable, powers for reconstitution, injection formulations in vials or ampoules
- HPLC based method development
- Assay, dissolution, stability indicating methods, degradation products, cleaning methods, content or blend uniformity
- Preservative assay, preservative efficacy, water content, particle size
- Analytical testing for formulation development support
- In-process, release, or stability testing
- GLP/GMP
- Method validation, method verification, and method transfer
- Solving problems with product stability
- All ICH stability conditions
- Developing stable products with desired shelf life
- Manufacturing clinical trial material for pilot bioequivalence studies or Phase I clinical trials
- US-based or international CRO selection, pricing negotiations, quality audits, protocol review
- Managing all aspects of bioequivalence or pharmacokinetic clinical studies
- Managing all aspects of working with CMO, from identification through product approval
- Manufacturing process development and optimization at R&D scale
- CMO identification, selection, contract negotiations, audits
- Tech transfer and process development at CMO
- Solving manufacturing problems such as lack of process control, blend and content uniformity failure, or batches failing to meet release specifications
- Developing and filing for patents around your products for enhanced exclusivity
- Non-infringing Para IV ANDA product development
- Consulting on all formulation, clinical, API related, dosing related patent issues
- Vici offers all services that an internal R&D department offers parent companies
- Partner with us to receive all the benefits of having your own internal R&D group without the cost or headache associated with creating and maintaining an internal R&D group
- Product development report in the CTD format
QbD, risk assessment, FMEA - Pre-IND, IND documentation and filing
- FDA controlled correspondence
- Writing all CMC sections of an ANDA or 505(b)(2) NDA filing
- Managing all aspects of ANDA or 505(b)(2) filings and approval through our preferred regulatory services provider
REQUEST A QUOTE
Use the form below for your quote request. We will respond within 24 hours.
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How Vici Can Help
- The team at Vici are experts in drug product development, including formulation development, analytical development, and regulatory support. Vici can help with products ranging from oral tablets, oral liquids, injectable liquids, and ophthalmic liquids. We also have a strong network of third-party support for any testing or regulatory work that is not conducted in-house.
- Vici has experience in selecting claims for patents and in assisting in authoring to help you protect your product from being genericized.
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We're Here To Help
We can help you with all your formulation needs. Please call or message us to directly talk to the formulation SME at Vici.
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