Aditi Joglekar

Founder & Managing Director

There has been an exponential growth in the number of preventive solutions for various kinds of illnesses. According to market reports, the estimated value of preventive healthcare in India will amount to $197 billion by the end of 2025. There has been the emergence of various startups that are using advanced digital technologies and AI to gather and analyze lifestyle data and drive the sector of preventive healthcare.

However, despite having advanced facilities and required capital, many corporations lack the expertise and experience that is necessary to manufacture sustainable products for the market. These production processes have unique elements involved along with several layers of complexities. Clients often face challenges in maintaining the life-cycle management of the products that result in deteriorated production lines.

AVChiT Biosolutions was founded to address a critical gap in the industry by offering comprehensive, end-to-end services rooted in extensive industry experience and expertise. These services are designed to help companies achieve long-term sustainability in the market. Dr Aditi Joglekar, the Founder & Managing Director of AVChiT Biosolutions, holds a Ph.D. in Cancer Biology and brings over a decade of experience working with renowned healthcare organizations. Her expertise spans a wide range of requirements, including the set-up of manufacturing facilities, testing labs, and operational processes, making her well-qualified to provide strategic advice and guidance.

AVChiT Biosolutions excels in developing Quality Management Systems (QMS) and Computer System Validation (CSV) for pharmaceutical and biopharmaceutical manufacturing and testing facilities. These are areas of specialization for Aditi, who has independently consulted on many complex projects.

As a cell biologist, Aditi has extensive expertise in bioanalytical and bio characterization assay development, qualification, and validation. She has accumulated substantial knowledge in quality compliance, laboratory and facility setup, and technical writing. "My experience as a user of computer systems and in adhering to quality compliance at research and manufacturing facilities has given me a deep understanding of the challenges users face. These are the exact challenges I aim to solve for my clients. Our expertise encompasses quality consulting, bioassay development, technology transfer and process development, computer system validation, facility and laboratory setup, training, and audits", stated Aditi Joglekar, Founder & Managing Director, AVChiT Biosolutions.

Acceleration through Collaboration

As the country is growing as a recognizable name in the pharmaceutical industry, consultation requirements for different kinds of processes are also increasing. AVChiT Biosolutions understands this precisely and provides efficient solutions guided by a core team of individuals with immense experience and expertise in different niche domains. This collaboration with experts has given the company a diverse outlook on consultancy.

There are a multitude of regulatory guidelines and frameworks that manufacturing and testing facilities in the pharmaceutical industry must follow to ensure accuracy in compliance. As the pharmaceutical industry is dedicated to well-being of the society, it becomes imperative for organizations to follow all the compliance norms and deliver good quality products in the market. With the emergence of cell and gene therapy for targeted treatment, there is a need to invent newer characterization methods and processes. Quality compliances and regulatory requirements are redefined. AVChiT Biosolutions can create an accurate compliance framework for clients.

Aditi Joglekar is a highly experienced consultant specializing in Computer Systems Validation (CSV) for the pharmaceutical and biopharmaceutical sectors. With a strong foundation in regulatory compliance, she ensures that all computerized systems involved in production, quality control and analytical facilities adhere to rigorous industry standards, including FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines. Aditi's expertise covers the complete CSV lifecycle, from risk assessments and validation planning to protocol development, execution, and final reporting. She is proficient in conducting comprehensive gap analyses and developing remediation plans to ensure systems are audit-ready.

“An increased demand of experienced and expert personnel can be observed arising from different sectors of the health and wellness ecosystem including pharmaceuticals, biotech, biopharmaceuticals, and nutraceuticals. New molecules are coming into the scenario in terms of cell and gene therapies, targeted treatments, and likewise. We are completely equipped to support facility development, characterization and validation of the molecules, end to end quality consulting and implementation support in all the sectors of the industry”, mentioned Aditi.

Focus on Customization

With the rise in the number of targeted therapies, new trends in manufacturing and testing are also entering the industry. New regulatory standards are being set by medical authorities across the world regarding manufacturing and quality management systems and compliances. In many cases, it can be seen that despite having an effective product, a manufacturer is unable to scale up production because of a lack of new technologies and their effective use. AVChiT Biosolutions’ team of experts have all the required knowledge about the latest products and technologies coming into the industry and are also aware of the quality and regulatory standards that manufacturers need to live up to gain sustainability in the market.

“Many a times, what comes to light are clients requiring consultancy regarding product purification processes to accurately comply with the regulatory standards. Our capabilities equip us to provide end-to-end solutions in these areas and inspect all parameters required in such facilities. Based on the need and specific requirement, we support troubleshooting of pain points, improvisation in yields or a complete transformation of the process into latest and cost-effective technologies. We are focusing a lot on customized services because of the changing dynamics of the industry”, said Aditi.

Future Projections

Since its inception in 2022, the company has gained considerable trust in the market because of its immense experience, delivering on timelines and value for money solutions. It is currently serving clients from various sectors like education, research, nutraceuticals, and medical consumables industry. Aditi has worked on various elaborate projects in biopharmaceuticals consultancy. AVChiT Biosolutions has demonstrated effective quality management system development, implementation and support on day to day activities. The same has been appreciated by regulatory bodies, customers and auditors alike.

Looking ahead, AVChiT Biosolutions aims to expand its client base and provide comprehensive consultancy services across the biopharmaceuticals, vaccines, and biologics sectors. Its commitment to delivering solutions that are compliant with current regulatory requirements, while prioritizing user experience and operational efficiency, distinguishes AVChiT Biosolutions apart as a biopharmaceutical consultancy. “We are dedicated to collaborating on projects to ensure timely delivery and excellence. AVChiT is eager to work with a diverse range of clients, from small and large manufacturing setups to startups and entrepreneurs. Our goal is to become one of the most trusted consultants in this domain", concluded Aditi.