Services
Pharmaceutical and biotech companies often face several common challenges that can be effectively addressed by MK Bio Consultancy, which specializes in CMC support and project management.
Explore how we can support in turning your vision into reality!
Vendor Selection
Identifying a Contract Manufacturing Organization (CMO) that alligns with specific needs can be difficult. MK Bio Consultancy can assist in crafting a detailed Request for Proposal (RFP) to attract qualified vendors as well as in streamlining the vendor qualification process based on capabilities, quality and compliance of potential partners.
Technical Transfer
When transferring processes between teams or sites, miscommunications and misunderstandings can arise. With help of MK Bio Consultancy it is possible to manage these transfers effectively, ensuring all parties are alligned and that knowledge is properly transferred.
Scale-up
Transitioning from small-scale production to full-scale manufacturing can present significant hurdles. MK Bio Consultancy can provide guidance on effective scale-up strategies to ensure smooth transitions and maintain product quality.
Process validation
Ensuring that processes, equipment, and systems are properly validated is critical. MK Bio Consultancy can facilitate the validation process, helping companies meet compliance requirements.
Project management
Many organizations lack the internal resources or expertise for effective project management. MK Bio Consultancy can provide seamless project oversight, ensuring timelines are met, budgets are adhered to, and communication flows smoothly among stakeholders.
Training On Demand
This custom-tailored service is designed to enhance the skills and knowledge of teams in the biopharmaceutical industry. Each training session is customized to meet specific needs of your team or organization, ensuring relevance and immediate applicability. Participants benefit from practical insights and best practices that drive operational efficiency and compliance in complex environments.
About Us
Marta Kijanka, PhD
Managing Director of MK Bio Consultancy
In 2021 I founded MK Bio Consultancy to leverage my extensive expertise in the biotech and pharmaceutical sectors, particularly in CMC support and project management. Recognizing the common challenges faced by companies in these industries, I aim to provide tailored solutions that enhance efficiency, ensure regulatory compliance, and drive succesful outcomes.
My vision is to create a consultancy that not only offers strategic guidance but also fosters strong partnerships, helping clients navigate the complexities of drug development and manufacturing.
Please visit my Linkedin profile for further details about my background and professional experience.
Contact Us
MK Bio Consultancy is your partner for strategic CMC support and seamless project management. Right from selecting your best-fit CMO to executing successful process validation, MK Bio Consultancy is here to help.
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