Yogita Upadhyay

Founder

Any medicine that makes it to the market has a jour­ney much longer than mere laboratories and man­ufacturing factories. At the back of every approval is a system of verification, documentation and compliance that brings security to the patients as well as global ac­countability.

With pharmaceutical markets going global and new areas such as biosimilar, orphan drugs and per­sonalized medicine gaining ground, regulating expertise has become crucial as research itself. To navigate this com­plex terrain having only technical expertise is not enough, it also requires foresight, agility, and a clear grasp of evolv­ing standards.

It is based on this realization that Regpharm Consultancy has been establishing itself as an ally that can be relied upon by pharmaceutical and life sciences companies. The consultancy was founded by an experienced regulatory expert who has worked across the industry in senior positions over the past eleven years.

What started as a vision of serving the pharmaceutical ecosystem with compliance, transformed into a wider purpose—to direct companies through the complicated global demands as well as training the future professionals.

Since its inception, the consultancy has integrated its regulatory affairs, formulation development and R&D support to develop a platform for its clients in both regional and stringent international markets.

Expertise Anchored in Experience

The strength of Regpharm Consultancy lies in its team of seasoned professionals who bring deep regulatory and scientific expertise to the table. Over the years, the consultancy has built the capacity to respond to queries issued by regulatory bodies in various geographies which ensures that clients have the confidence and consistency in their compliance process.

Adding to this, the team’s expertise include over 400 formulation development ranging from pilot-scale batches to commercial level, which reflects its capacity to combine regulatory knowledge with realistic pharmaceutical development.

In addition to the dossier compilation and query resolution,Regpharm Consultancy assists companies in developing new products, preparing method development reports, and in-depth documentation in accordance with the standards prescribed by the world agencies such as EU, ANVISA, WHO, and PIC/S.

“Our involvement in formulation development and technology transfer ensures that regulatory approval is not only a procedural milestone but a step towards sustainable market entry”, says Yogita Upadhyay, Founder, Regpharm Consultancy.

Clients tend to approach regulatory consultants when they need to but are left dissatisfied when they seek information after submission. To fill this void, Regpharm Consultancy has developed a reputation of long-term client support, transparent communication, and practical problem solving. This emphasis has assisted the consultancy to build long-term relationships and establish itself as a reliable name in the sector.

Building Value Through Knowledge & Responsibility

Regpharm Consultancy's journey has not only been about compliance, but also about making channels of knowledge for the future. The consultancy realized that there is no organized learning in regulatory affairs and has been undertaking educational initiatives directed to both students and professionals.

These training programs are aimed to fill the gap between the theoretical knowledge in academies and the industry expectations, simplifying the regulatory sciences and making them more practical.

The individualized solution is another feature of Regpharm Consultancy's approach. Instead of working on a one size fits all model, the consultancy tailors its services to the specific needs of a particular client. “This philosophy of the consultancy is based on responsibility not just to clients but also to the wider pharmaceutical environment where ethics and sustainability are becoming central to practice”, mentions Yogita.

The advocacy of women in the pharmaceutical industry also lies in the core of the philosophy of the consultancy. Yogita’s personal desire to support women professionals and entrepreneurs in what has long been male-dominated field is indicative of the vision of inclusivity. Regpharm incorporates a human touch into its technical expertise by uplifting the voices that are usually underrepresented.

A Vision Beyond Compliance

While its foundations are firmly established in regulatory consulting, it is looking toward an ambitious future. It is also planning to venture into contract research organization (CRO) services that will provide a more expansive service to the pharmaceutical and biotech companies.

Similarly, it is about to roll out structured programs in regulatory affairs and other related areas—including healthcare systems, medical devices, and clinical practices. These initiatives are meant to nurture the future generation of professionals who would be capable of addressing the emerging demands of the industry.

Guided by its tagline, “Navigating Regulation, Ensuring Excellent Path”, it envisions a future where compliance is not seen as a barrier but as an enabler of growth. “With the combination of expertise, education, and inclusivity, Regpharm Consultancy is positioning itself as not just a service provider but a partner in shaping a more informed and resilient pharmaceutical ecosystem”, concludes Yogita.