Consulting Services

Expert guidance for biotechnology and pharmaceutical development

Overview

Daktari Biotechnology offers comprehensive consulting services to biotechnology companies, research institutions, and healthcare organizations. Our team of experienced consultants provides expert guidance on regulatory compliance, process optimization, technology transfer, and market access strategies, helping clients navigate the complex landscape of biotechnology development and commercialization.

Our Consulting Services

Regulatory Affairs

Guidance on regulatory requirements, submission preparation, and regulatory strategy development.

Process Development

Optimization of manufacturing processes for improved efficiency, quality, and scalability.

Quality Management

Implementation and improvement of quality management systems to ensure compliance with international standards.

Technology Transfer

Support for effective transfer of technologies between organizations or from research to manufacturing.

Training & Education

Customized training programs on various aspects of biotechnology development and manufacturing.

Strategic Planning

Development of strategic plans for research, development, and commercialization of biotechnology products.

Our Approach

Our consulting approach is tailored to each client's specific needs and challenges. We follow a structured methodology to ensure effective solutions and measurable outcomes:

Assessment

Comprehensive evaluation of current state, challenges, and opportunities to establish a baseline.

Strategy Development

Collaborative development of tailored strategies and solutions to address identified needs.

Implementation

Hands-on support for implementing recommended solutions and strategies.

Monitoring & Optimization

Continuous monitoring of outcomes and refinement of approaches to ensure optimal results.

Knowledge Transfer

Building client capabilities through training and knowledge sharing to ensure sustainable success.

Case Studies

Regulatory Strategy for Novel Vaccine

Developed a comprehensive regulatory strategy for a novel vaccine, resulting in successful regulatory approval in multiple African countries.

Challenge: Complex regulatory landscape with varying requirements across different countries.

Solution: Tailored regulatory strategy with harmonized documentation and targeted engagement with regulatory authorities.

Result: Accelerated approval timeline by 30% and successful market entry in 5 countries.

Manufacturing Process Optimization

Optimized biologics manufacturing process for a pharmaceutical company, improving yield and reducing costs.

Challenge: Inefficient production process with high costs and variable product quality.

Solution: Comprehensive process analysis and implementation of targeted improvements in critical process parameters.

Result: 40% increase in yield, 25% reduction in production costs, and improved product consistency.

Quality Management System Implementation

Implemented a comprehensive quality management system for a startup biotechnology company.

Challenge: Need for robust quality systems to support regulatory compliance and product quality.

Solution: Developed and implemented tailored quality management system aligned with international standards.

Result: Successful ISO certification and establishment of foundation for regulatory compliance.

Our Solutions

Our Expertise

15+ years of industry experience
Team of specialized consultants
Experience across multiple markets
Regulatory expertise in African markets
Technical knowledge in biologics and pharmaceuticals
Track record of successful projects

Testimonials

"Daktari's consulting team provided invaluable guidance that helped us navigate complex regulatory requirements and accelerate our product development."

Dr. Sarah Johnson

CEO, AfriHealth Biologics

"The process optimization expertise from Daktari Biotechnology transformed our manufacturing operations, resulting in significant cost savings and improved product quality."

Michael Ochieng

Operations Director, PharmaTech