Welcome To WiTii : A Global Pharma Consulting Firm

WITII PHARMA CONSULTING

A Global Pharmaceutical Consulting Firm that provides high-quality consulting services to pharmaceutical companies. We specialize in Drug Development and CMC services related to Generics, Complex Generics and 505(b)(2).

WiTii Consulting LLC

About Us

At WiTii, we are a global pharmaceutical consulting firm that excels in providing reputable and efficient consulting services to assist with the development pipeline of generics, 505(b)(2) applications, and more. As an emerging global consulting company, we take pride in supporting the global generic pharma sector. As a pioneering global pharmaceutical firm, we are acutely aware of the surging demand for generics that is reshaping prescription drug expenditure in the U.S. and across the world and strive to meet the rising needs of companies in the field.

With 25 years and counting of active experience in the global pharmaceutical industry, WiTii is uniquely poised to supercharge your generic, complex generic, and 505(b)(2) drug development initiatives. We strive to offer inventive solutions that will expedite your development programs, and we hold a strong conviction in swiftly and effectively positioning your products in front of the FDA. We always endeavor to take a strategic approach to your specific project needs, so as to mitigate potential risks in your drug development journey, while allowing your strengths to shine. 

With a focus on startups, mid-sized companies, and emerging companies, our diverse client base attests to the breadth of our expertise. WiTii Consulting’s service portfolio, ranging from idea generation to commercialization, is comprehensive and thorough. Our tailored consulting prowess is expansive and evolves in tandem with your project’s needs. Our ultimate goal is to deliver the most impactful and efficient return on your investment through our global pharmaceutical consulting firm expertise.

With WiTii, you can be confident in your quest of achieving your goals.

Why Us

Our Strengths

Strong Network

At WiTii, we have a strong network of CDMO/CMO/Channel partners across the globe. With a network of more than a hundred contract development, contract manufacturers, contract research organizations, and drug development companies across the globe, we are confident in our ability to help you reach your goals.

Sound Technical Knowledge

We have extensive knowledge and expertise in the following areas: Generics, Complex Generics (ANDA), 505(b)(2), Drug Development, Licensing, and Co-development.

Global Experience

Our team has experience in global clinical trials and global regulatory filing, quality, compliance, and manufacturing in the United States, Asia Pacific, and European Union.

What We Offer

Services

Our client base ranges from single-employee startups, mid-sized companies and emerging 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

Contact Us

General Inquiries

Address: 1499 W. 120th Avenue, Suite 110, Denver, CO, 80234.

Email: admin@witii.us

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