Regulatory Documentation and Support
- Regulatory review strategy including evaluation of the best FDA filing pathway
- Preparation, compilation, review, and submission of all eCTD Modules
- Complete IND, Investigator Brochure, NDA, 505(b)(2) and ANDA regulatory support including writing, review, compilation, publishing and filing
- Active and inactive ingredient source review and evaluating compliance to regulated markets
- DMF evaluation
- LOA request and compilation
- Genotoxic impurities risk assessment and strategy
- Nitrosamine assessment and testing
- Controlled correspondence preparation and submission
- Inactive ingredient levels
- Q1/Q2 for ANDAs
- Reference product selections for 505(b)(2) NDAs and ANDAs
- Controlled correspondences related to regulatory strategy
- Solicit bids from clinical regulatory experts, CROs, toxicological assessment experts, and clinical packaging companies
The FDA and pharmaceutical companies are paying increasing attention to nitrosamine impurities in drug products. Nitrosamine impurities may be carcinogenic and the FDA is working with the industry to study and control them in products. There have been high profile product recalls that have caused supply disruptions and affected patients adversely. Part of the strategy for addressing this issue is for manufacturers to perform risk assessment on the drug product and test for nitrosamines when needed. In some cases, re-formulation may be needed to prevent supply disruptions. Vici can be your one-stop-shop for nitrosamine impurity assessment and re-formulation needs. We work quickly and efficiently to ensure new products introduced remain free of high-risk nitrosamine impurities and help you with existing products needs to prevent supply disruptions. As part of this service, we can:
- Perform nitrosamine impurity risk analysis
- Perform nitrosamine testing on your product, if needed
- Work with established third-party vendors to assess any novel nitrosamine impurities that may exist for mutagenic potential
- Perform a nitrosamine root cause analysis
- Remediate and re-formulate your product, if needed to reduce nitrosamine impurity formation in the drug product to ensure supply continuity
Per ICH guidance, stability studies need to be performed to determine product shelf life prior to approval. This occurs beginning in early R&D through registration batches and commercial product manufacturing.
Sponsors are expected by the FDA to provide stability data as part of IND, NDA or ANDA filing. In addition, post-approval changes to the formulation, raw ingredients, manufacturing process or location require stability studies.
Vici routinely conducts stability studies per ICH recommendation at the following conditions.
- Long term – 25°C ± 2°C/60% RH ± 5% RH
- Intermediate – 30°C ± 2°C/65% RH ± 5% RH
- Accelerated – 40°C ± 2°C/75% RH ± 5% RH
Tech-Transfer and CMO Management
- Solicit bids from CMOs and negotiate pricing, CMO selection
- CMO management: Vici routinely works with CMOs in the US and globally. Vici also has a small, highly qualified tech transfer team lead by a PhD formulation scientist. We are able to manage CMO projects for you globally.
- CRO selection and management for bioequivalence and pharmacokinetic studies
- Evaluate dossiers, batch records, and validation reports for tech-transfer and perform CMC gap analysis
- Providing site transfer strategies including SUPAC review