Injectables
Developing injectable formulations requires an experienced understanding of choosing the correct active and inactive ingredients, selecting the appropriate packaging components, optimizing the correct manufacturing process, assessing and managing risk, and designing a testing plan which takes into consideration a control strategy. Our scientists have developed a variety of injectable formulations whether it be at small scale or overseeing injectable formulation tech transfers to commercial contract manufacturing organizations (CMOs).
At Vici, we’re experts in both the R&D and regulatory aspects of early-stage injectable development and we’re here to guide both you and the CMO to guarantee quick, low-cost formulation solutions.
Our sourcing team finds the best suppliers of active ingredients (API), inactive ingredients, and packaging materials based on our technical and regulatory know-how, saving you time and money. We’ve developed tech transfer packages for small molecule and peptide injectable formulations, facilitated tech transfers, and successfully written full ANDA filings.
Elements of Tech Transfer Package Preparation and Regulatory Filing Offerings
Source(s) of Active Pharmaceutical Ingredient (API)
Source(s) of active pharmaceutical ingredient (API) which are suitable for FDA filing and sterile manufacturing.
Source(s) of Inactive Ingredients & Packaging Components
Source(s) of inactive ingredients and packaging components with the correct regulatory documentation and technical specifications.
Optimal Manufacturing Process (including protocols)
Optimal manufacturing process including protocols to ensure sterility, such as autoclaving, sterile filtration, and/or filter material selection.
Established Product Stability
Product stability established through small scale stability studies.
Complete Analytical Method Development
Complete analytical method development, validation, and method transfer.
Scale-up Strategy
Scale-up strategy and batch record preparation.
Full CMO Technical and Project Management
Full CMO technical and project management on behalf of our clients, including review of all technical documentation at the CMO – specifications, in-process and finished product testing strategy, batch records, method transfer protocols, stability protocols.
Full Review of All Technical Data
Full review of all technical data generated at the CMO.
ANDA and/or NDA
ANDA and/or NDA writing and filing.
At Vici Health Sciences, we are knowledge experts in the field of small molecule and peptide drug product development. We can manage your ANDA, 505(b)(2), and 503B compounding injectable projects – from concept to clinic. Contact us today!