For biotech and medical companies, the regulatory process is a confusing mess. She’s cleaning it up.

In 2022, Rama Doddi took a big risk. She left her home in Visakhapatnam, India; waved goodbye to her young family; and shut the door on a decade-long career in human resources to pursue an education—and a career—in regulatory affairs in the United States.

“I just always felt like I was missing something in my life,” says Doddi, who will graduate from Northeastern University’s College of Professional Studies this year. “My career was going well, but it wasn’t my passion.”

In some ways, this internal drive was confounding. Doddi had married her husband just after they both graduated with masters degrees. They had a daughter whom they love. Doddi had a solid job at IBM. But still, something nagged at the back of her mind. Ultimately, with her family’s encouragement, Doddi traveled to the U.S. to embark on the two-year regulatory affairs program at Northeastern.

Driven, and with intense focus on the end goal, Doddi instantly made connections with her professors. She explained her background and where she wanted to go, which is to say: a biotech company. It didn’t take long. By September 2023, Doddi had landed an internship at a Brooklyn-based biotech company, where she was tasked with doing some research for a new medical device the company was interested in developing.

She had to immerse herself in the world of this device: Were there comparable devices already on the market? What was the regulatory pathway to getting this device to customers?

“​​That was a big task, but a very interesting one for me,” Doddi says. It required her to read through dense guidance documents that could go on for 90 pages or more. Plus, she was eager to catch up with her younger counterparts in the field. In her mid-30s, Doddi felt the pressure to make up for the decade she spent in HR—gaining valuable experience that was, nonetheless, far from the task at hand in New York.

“At one point I was sitting in my Airbnb room, thinking that there has to be a better way,” she says.

And then it occurred to Doddi: Why not her?

This is how Doddi’s venture, RegINTL, was born. It’s designed to help small- to medium-sized companies (much like the one at which Doddi interned) map out their particular regulatory landscape—and then provide solutions for navigating it.

Doddi’s venture and her entrepreneurial spirit grabbed the attention of the judges for this year’s Northeastern University Women Who Empower Innovator Awards. The annual awards honor entrepreneurs for their innovative, boundary-pushing work. This year’s recipients—students and alumni from the Northeastern community—were selected by a panel of judges and will receive a total of $500,000 in funding. Doddi was honored among graduate student award winners.

“RegINTL addresses a significant gap in the regulatory affairs market by offering highly specialized services to navigate the complexities of global regulatory frameworks,” says Vaishnavi Dasari, one of the company co-founders.

“In industries like pharmaceuticals, where strict compliance and risk management are crucial, companies often face challenges with inconsistent international regulations,” Dasari says. “RegINTL leverages its expertise to provide customized solutions that optimize regulatory strategy, accelerate market entry, and minimize compliance risks by aligning operational efficiency with regulatory demands.”

Doddi’s venture comes at the right time. Just as she was starting courses at Northeastern, President Joe Biden signed an executive order that assigned a handful of government agencies to coordinate a plan to modernize regulations around the development and manufacture of a wide range of biotech products.

To start, those agencies—including the U.S. Food and Drug Administration, Environmental Protection Agency, and the Department of Agriculture—solicited public feedback from drug manufacturers, biotech agencies, and medical device companies. The resounding theme? The U.S. regulatory landscape is confusing, duplicative, and offers little by way of guidance. And if you’re developing a product with an international market, it means wrangling with new regulatory schemes in each country.

“Companies like Pfizer or Moderna have their own dedicated teams for this,” Doddi says. “But smaller companies in markets like India, or companies with smaller teams in the United States need the support. Boston, especially, is a science hub. And we know there are a lot of small to mid-level companies here, which emerge each and every day.”

Doddi knew she couldn’t do this alone. The scale and scope were simply too big. So she assembled a team of 10 or so friends—all of them women, and all of whom have different backgrounds and specialities—over WhatsApp and asked what they thought.

“To my surprise, all of them have said yes and we became the core team,” she says. They messaged back and forth in a flurry, quickly settling into roles and crystalizing the idea for RegINTL. “We established the company, the plan, and it is going well.”

Dasari, one of the people on that group chat, describes Doddi as a dedicated leader.

“Rama is a visionary individual who has a real talent for spotting opportunities in the regulatory affairs industry,” Dasari says. “With a deep knowledge of regulatory compliance and a good grasp of industry trends, she’s great at leading teams to develop creative solutions. Her leadership is collaborative, and always moving forward.”

Doddi and the RegINTL team are building up their database and building capacity. Doddi’s daughter and husband moved in with her in New York (she’s no longer staying in an Airbnb) so they can be together while Doddi works full time at that Brooklyn biotech company and dedicates time to growing RegINTL.

Mostly, Doddi says she doesn’t want to look back and have any more regrets.

“I’m 35 now, and I don’t have the time that people in their 20s have anymore,” she says. “I want to be someone who tries, and who can have an effect on society while I’m working. So, the hurdles will be there, but we won’t have to stop for any reason.”