FREQUENTLY ASKED QUESTIONS
This is a standard approach to the implementation of a job at Makini. Each job whether formulation development, process control and technology transfer has its own methodical approach. Each approach was developed based on two decades of experience in formulation and manufacturing process development within the pharmaceutical industries and academic institutions.
Other scopes of work include regulatory affairs which encompasses new medicine registration, variations and renewals, risk-based approach . Our team has direct access to industry thought leaders and pacesetter who are accessible to all Makini Groups clients.
Indeed, our team of professionals can provide assistance to both food and cosmetic industries. Our approach to formulation and process development and optimization is risk-based hence, our codified value engineering approach will be similar but not the same as in the pharmaceutical industry.
Yes, we provide solutions and services to pharmaceutical companies globally. Our team is equipped to handle international regulations and market requirements.
Our medical devices are registered with official bodies like the TMDA (Tanzania Medicines and Medical Device Authority) and. Our medical devices are sourced from ISO 13485 accredited manufacturers and equipmenrigorous testing and are certified to comply with international and national certification standards. More details can be found on the products pages or by contacting us directly.
Yes, we offer ongoing/limited support and maintenance services , including troubleshooting, further training and updates as needed.
Understanding the importance of maintaining consistent product quality and minimizing process variability is key to ensuring product safety, efficacy and regulatory compliance.
A well documented knowledge and experience gained during development and commercialization at the transferring site, provides relevant data, and the know-how, that can be leveraged in the manufacture and commercialization of the same product at the receiving site (an authorized third party).
Digital adoption integrates advanced technologies to optimize manufacturing, improve operational efficiency, and support data-driven decision-making.
Our training sessions cover essential topics such as process control, technology transfer, and digital adoption, aimed at empowering your teams with practical skills and long-term problem-solving capabilities.
We leverage extensive local and international experience to align our processes with regulatory requirements, ensuring that all our solutions adhere to the highest standards of quality and safety.
We work closely with our clients to understand their specific challenges and design customized strategies that address their operational and regulatory requirements.
Our process control systems ensure consistent quality and safety by monitoring and regulating production variables continuously.
By minimizing variability and maintaining strict quality standards, our process control solutions help you meet industry regulations and avoid costly disruptions.
Continuous process verification uses real-time data analytics to determine monitor the state of production process, offering greater accuracy in the prediction of process failure and allowing for timeous remediation than traditional periodic (annual monitoring) checks.
We streamline the transfer of critical knowledge and experience gained during development and commercialization by assessing processes, ensuring that new products reach the market faster while adhering to regulatory standards.
Common challenges include knowledge gaps and process inconsistencies. Our tailored approach and experienced team ensure a seamless transition.
Implementing advanced digital tools optimizes production workflows, enhances data-driven decision-making, and improves overall operational efficiency.
Investments in process control can lead to significant cost savings, improved product quality, and reduced downtime—benefits that compound over time.
