MK Bio Consultancy was founded in 2021 to leverage extensive expertise in the biotech and pharmaceutical sectors, with a focus on CMC support and project management. Recognizing the common challenges faced by companies in these industries, the company provides tailored solutions that enhance efficiency, ensure regulatory compliance, and drive successful outcomes.
From vendor selection and technology transfer to scale-up, process validation, and project management, MK Bio Consultancy offers support at every stage, helping clients navigate complex processes smoothly. Additionally, the company provides on-demand training, delivering customized educational solutions to ensure teams remain well-informed and aligned with the latest industry trends and best practices.
The company's vision is to build strong, collaborative partnerships with clients, helping them manage the complexities of drug development and manufacturing while fostering long-term success.
MK Bio Consultancy - Your partner in CMC!
Our services include:
1. Assistance in crafting detailed Requests for Proposal (RFPs) and streamlining the vendor qualification process to identify and select Contract Manufacturing Organizations (CMOs) that align with specific needs, focusing on capabilities, quality, and compliance.
2. Facilitation of smooth process transfers between teams or sites by ensuring alignment, effective communication, and proper knowledge transfer to prevent misunderstandings and miscommunications.
3. Guidance on effective scale-up strategies to ensure smooth transitions from small-scale production to full-scale manufacturing while maintaining product quality.
4. Facilitation of the validation process, to ensure meeting compliance requirements.
5. Seamless project management, ensuring timelines, budgets, and stakeholder communication are effectively managed for successful project delivery.
6. Customized training sessions tailored to the specific needs of your team or organization, providing practical insights and best practices to enhance skills, operational efficiency, and compliance in the biopharmaceutical industry.
