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.

Contract Development

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.

We’re Here to Help

Contact us today for a quote. We will be sure to respond to your request within 24 hours.

1-410-379-1500

CONTACT US

Services Offered 

Formulation Development
  • Solid and liquid oral dose formulation development
  • Injectable formulation development
  • Complex formulations
  • Extended release formulations
  • Tablets, capsules, oral solutions and suspensions, ODT, extended release suspensions, chewable, powers for reconstitution, injection formulations in vials or ampules
Analytical Methods
  • 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 qualification, method verification, method transfer
Stability Studies
  • Solving problems with product stability
  • All ICH stability conditions
  • Developing stable products with desired shelf life
Clinical Studies
  • 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
Manufacturing Tech Transfer
  • 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
Patents
  • 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
Full-Service R&D
  • 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
Regulatory Documentation and Filing
  • 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

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Use the form below for your quote request. We will respond within 24 hours.

Get In Touch

We’re Here to Help

Contact us today for a quote.
We will be sure to respond to your request within 24 hours.

Location

6725 Santa Barbara Court,
Suite 107,
​Elkridge, MD 21075