RegDev, Inc
Benchmarking Quality in Consultation Services

RegDev was founded by Sid Senroy nine years ago as a boutique clinical development services company. Over the past 25 years, Senroy has spearheaded myriad global quality and compliance business units as an executive and senior consultant, launching new drugs that have cumulatively grossed over 30 billion dollars. He specializes in helping companies pass compliance assessments, develop robust quality systems and prepare for FDA reviews and inspections.

Today, under his leadership, RegDev offers a full range of consultancy services to biopharmaceutical companies across the globe for building robust quality management systems and improving regulatory compliance. Their team of highly experienced and committed consultants are industry veterans—including ex-FDA and ex-MHRA officers—who specialize in process optimization.

Sid Senroy’s sensitivity to cultural nuances and leadership skills have been instrumental RegDev’s cross-functional alliances for growth and expansion on a global scale. Most recently, they acquired Essential Pharmacovigilance, a boutique Drug Safety & Pharmacovigilance consulting firm developed and owned by Catherine Baldridge, to add those capabilities to their service suite for offering clients consultation, auditing and monitoring in full-service capacity.

Baldridge is a valued advisor and consultant to the industry, providing strategy and services across pharmacovigilance, including GVP operational support, department development, inspection remediation, SOP writing and training, REMS, and GVP gap analysis, auditing and inspection readiness activities. she is an industry speaker, former member of the DIA community leadership counsel, and former member of the planning committee for annual safety conferences. Currently, she is an Adjunct Faculty member at the Temple University, Graduate School of Pharmacy and also leads the RegDev team as the Head of Safety Affairs.

“By joining forces with Essential Pharmacovigilance, we seek to become a one-stop shop for clients across the pharma space,” says Sid Senroy, President, RegDev.

Being a highly regulated industry, most small and mid-size companies outsource their work to third-party vendors for better agility. However, in a sea of service providers, these companies often lose vendor oversight which ends up having the opposite effect on their processes. Addressing this innate nature and challenges of the industry, RegDev helps clients bridge the gap between their current vendors or establish new connections with others.

RegDev’s multinational team is dedicated to delivering uniquely tailored and personalized services to help their clients ensure successful regulatory inspections and drug approvals. RegDev conducts business with the highest standards of integrity, ensuring that clients’ sensitive information stays confidential. Having started out as a quality and compliance firm, the company has added other capabilities to their portfolio of services over the years, such as clinical operations and development, regulatory affairs, computer validation, and medical writing.

RegDev offers a direct, one-to-one service offering while expanding to a new market or coming up with a new product. This includes expert guidance around audits and inspections, risk management, GXP (good practice) consulting, risk management, Quality Management Systems (QMS) assessment, development and implementation, along with ongoing support and training.

RegDev also helps clients address operational challenges. The company conducts gap analysis on the clients’ systems to review their existing procedures and compares them to the current regulations for ensuring compliance. If non-compliant, they help clients bridge the gap and improve their systems for operational efficiency.

We aim to impart education and develop a knowledge base within the company and with our clients

A major driver for RegDev’s progressive growth has been their client-focused approach. The company begins client onboarding by understanding their pain points and formulating a plan that is efficient at mitigating the risks in a cost-effective way. Their customized services assess the clients’ unique situations and provide strategies—from a safety, regulatory or clinical perspective—to help achieve their goals.

RegDev is also committed to working closely with their clients to build a strong and long-term partnerships. The company does not follow a sales or marketing strategy to attract customers and relies on the inquiries they receive through word-of-mouth and referrals from their existing customers.

RegDev’s team works well together and in conjunction with their clients’ teams. They also educate the C-suite executives on the importance of being compliant and having quality procedures, which benefit the patients, and the public. “We aim to impart education and develop a knowledge base within the company and with our clients,” emphasizes Baldridge.