SERVICES
Our client base ranges from single-employee startups, mid-sized companies and emerging companies in the pharmaceutical and life science spaces.
How do we work with our clients?
Ad hoc
Ad Hoc consulting is provided on a temporary or as-needed basis, typically for a specific project or problem. Unlike long-term consulting engagements, which may involve ongoing support and collaboration, ad hoc consulting is more focused and limited in scope.
Fixed hourly rate.
Short & Long Term Projects
Our short and long-term consulting service refers to a type of engagement that is of a specific duration, typically ranging from a few days to up to a year or more. It is designed to provide targeted assistance to clients who has specific needs or objectives.
Fixed hourly rate, bi-weekly or monthly billing.
Fixed Price
Fixed price consulting services are provided at a predetermined, fixed cost. In this arrangement, the consultant and the client agree on a specific fee for the entire consulting engagement, regardless of the actual time or effort required to complete the project.
The client knows the exact cost of consulting the project upfront, which helps with budgeting and financial planning. Billed monthly.
OUR SERVICE OFFERINGS
Our client base ranges from single employee startups to large global companies in the pharmaceutical and life science spaces.
Drug Product Development
Our collective expertise allows us to provide our clients with a full range of Drug Development services, with a particular focus on generics. These services range from pre-formulation to commercialization and include:
- Strategic Pharmaceutical Project Management
- Project Management Oversight
- 505(b)(2) Literature Review
- Broad NDA and 505(b)(2) assistance for Generics
- NDA and ANDA Filing Support
- Contract Negotiation
- Project Planning and Integration
- 505(b)(2) Phase I-III Clinical Support
Chemistry, Manufacturing and Controls (CMC)
WiTii is able to offer comprehensive assistance with CMC in the drug development life cycle. We provide our clients with the following services:
- CMC assistance with various dosage forms (tablets/capsules, injectables, creams, liquids etc.)
- Batch size increase strategy, execution, and additional scaling support
- Quality by Design (QbD) Strategy and support
- FDA Communication and Write-up Assistance
- Project Development and Integrated Project Planning
- Extensive Submissions Assistance
Complex Generics Complete Package
As experts in the production and commercialization of generics, we are able to offer a full, one-stop-shop package of support for complex generics, in addition to services which focus on non-complex generics. Some of these services include:
- FDA Meeting, Correspondence and Review Assistance
- Product Specific Strategy and Management
- Pre-ANDA (PANDA) Package Preparation and Management
- Comprehensive Assistance with Various Dosage Types
- Extensive Support for Natural and Synthetic Peptide, Narrow-Therapeutic Index Small Molecule API, and Combination Products
Services Offered Through Our Partners
We have partnered with several experts in the field to provide a full spread of services in order to meet your specific needs. As WiTii continues to expand, so will these services. Presently, we offer the following through our partners:
- Support for Alternative Bioequivalence Approaches
- Clinical Study Protocol Development and Preparation
- High-Level Clinical and Preclinical Strategy
- Finding and Providing Vendors for Biostatistics, Clinical Technology and Central Laboratory Services
- Vendor Negotiation and Timeline Management
- Pharmacokinetics Assistance
- Support in establishing safety and efficacy
- Integrated Project Planning and Programming
General Inquiries
Address: 1499 W. 120th Avenue, Suite 110, Denver, CO, 80234.
Email: admin@witii.us