Our solutions
At Adaptis, we provide comprehensive solutions that empower healthcare
companies,
ensuring success across global markets with expert consulting in
pharmacovigilance and regulatory affairs.
Global Pharmacovigilance
Pharmacovigilance is monitoring and ensuring the safety of pharmaceutical products through vigilant adverse event reporting, risk management, and safety surveillance.
Global Regulatory Affairs
Regulatory affairs ensures that the pharmaceutical products comply with all regulations and laws governing their development, manufacturing, marketing, and distribution across the globe.
ANDA Parking and MA Holding
As the pharmaceutical manufacturers are facing an increasingly competitive environment and they are seeking out opportunities to reduce production costs.
Why Choose Us?
Integrated PV and RA Expertise
A dedicated team of pharmacovigilance (PV) and regulatory affairs (RA) experts, offering integrated approach from initial submissions to post-approval processes, ensuring synergies at every stage.
Experience in Authority Audits
Backed by extensive experience, including hands-on expertise in facing and clearing health authority inspections including pharmacovigilance and regulatory compliance audits.
Robust Operations and Delivery Systems
With strong operational frameworks and efficient delivery systems, we ensure the highest quality of solutions, meeting stringent timelines without compromising on standards.
Proven Track Record
Adaptis consistently demonstrates excellence and reliability in the global healthcare landscape by handling end-to end pharmacovigilance and regulatory operations for multiple clients.
Voices of Trust, Stories of Success.
Testimonials
Partnering with Adaptis has significantly enhanced our regulatory and pharmacovigilance
functions. Their expertise in end-to-end regulatory operations—from document compilation
and dossier review to seamless ANDA submissions and query resolutions—has been
invaluable.
Adaptis’s exceptional management of our pharmacovigilance functions ensures compliance
and precise safety monitoring. Their professionalism, meticulous attention to detail, and
proactive approach make them a trusted partner for all our regulatory and
pharmacovigilance needs.
The team at Adaptis made what seemed like a daunting regulatory process feel effortless.
Their dedication and personalized solutions have greatly benefited our operations. Highly
recommended!
Adaptis consulting solutions are top-notch. Their insights and strategies have not only
supported us in USFDA safety audit observation clearance but also upgraded our
pharmacovigilance systems for future compliance.
Adaptis went above and beyond to address our unique challenges. Their team’s dedication
and expertise in pharmacovigilance have contributed in our product’s post approval
surveillance. Outstanding solutions!
We were very happy to receive Regulatory Operational Excellence (ROE) and Regulatory
Document Design (RDD) solutions. These are very unique kind of solutions offerings from
Adaptis!
Adaptis demonstrated exceptional expertise and efficiency in managing our US ANDA Refuse-to-Receive response. Their team meticulously addressed every deficiency outlined in the Refuse-to-Receive letter and ensured our filing was fully compliant with US ANDA submission guidelines. Their proactive recommendations and strategic approach significantly streamlined our resubmission process. We deeply appreciate their dedication, professionalism, and commitment to delivering high-quality results within an impressive timeframe.
President – US-based Generic Pharmaceutical CompanyGentlemen,
I want to thank you for your outstanding effort in delivering the completed dossier. The relationship has been validated and the activities will grow from here. Please extend my thanks and congratulations to all of the members of Adaptis team that strived on our behalf.
Stay Informed, Stay Ahead with Adaptis
News and Blogs
Maximizing Regulatory Affairs/Pharmacovigilance Efficiency Through Outsourcing: A Competitive Edge for Small and Mid-Sized Pharma Companies
In today’s ever-evolving and highly regulated pharmaceutical landscape, managing regulatory affairs (RA) and pharmacovigilance (PV) has become a critical and resource-intensive responsibility.
Patient Safety and the Importance of Pharmacovigilance
Patient safety is a crucial part of healthcare that seeks to protect patients from harm during their treatment and care.
Understanding 21 CFR 314.80: Post marketing Reporting of Adverse Drug Experiences
21 CFR 314.80 is a regulation established by the U.S. Food and Drug Administration (FDA) to govern the post marketing reporting of adverse drug experiences.
Strategic Collaboration for Advancing Pharmaceutical Excellence!
Adaptis is delighted to announce the signing of a Memorandum of Understanding (MoU) with Poona College of Pharmacy, Bharati Vidyapeeth (Deemed to be University), Pune. This partnership aims to bridge the gap between academia and industry, fostering collaboration and expertise in the pharmaceutical sector.
A New Chapter of Growth and Unity!
With immense gratitude and joy, we celebrated the inauguration of our new office—a milestone made possible by unwavering support and blessings. The pooja and lamp-lighting ceremony symbolized the start of a journey filled with hope, unity, and ambition.
Proud Moment for Pharmacovigilance (PV) Team at Adaptis!
We are thrilled to have played a pivotal role in helping our client successfully clear their USFDA audit. Through our PV expertise in designing and implementing comprehensive Pharmacovigilance systems, strengthening SOP frameworks, and ensuring rigorous PV compliance...
Celebrating 5 Glorious Years of Adaptis!
𝑨 𝒔𝒘𝒆𝒆𝒕 𝒎𝒊𝒍𝒆𝒔𝒕𝒐𝒏𝒆 𝒄𝒂𝒍𝒍𝒔 𝒇𝒐𝒓 𝒂 𝒔𝒘𝒆𝒆𝒕 𝒄𝒆𝒍𝒆𝒃𝒓𝒂𝒕𝒊𝒐𝒏! From our humble beginnings to 5 years of 𝐫𝐞𝐬𝐢𝐥𝐢𝐞𝐧𝐜𝐞, 𝐢𝐧𝐧𝐨𝐯𝐚𝐭𝐢𝐨𝐧, 𝐚𝐧𝐝 𝐩𝐮𝐫𝐩𝐨𝐬𝐞-𝐝𝐫𝐢𝐯𝐞𝐧 𝐠𝐫𝐨𝐰𝐭𝐡, this journey has been truly special. A heartfelt thank you to our 𝐢𝐧𝐜𝐫𝐞𝐝𝐢𝐛𝐥𝐞 𝐭𝐞𝐚𝐦, 𝐯𝐢𝐬𝐢𝐨𝐧𝐚𝐫𝐲 𝐥𝐞𝐚𝐝𝐞𝐫𝐬, 𝐭𝐫𝐮𝐬𝐭𝐞𝐝 𝐜𝐥𝐢𝐞𝐧𝐭𝐬, 𝐚𝐧𝐝 𝐯𝐚𝐥𝐮𝐞𝐝 𝐩𝐚𝐫𝐭𝐧𝐞𝐫𝐬 who made this day possible...
Adaptis at Iphex 2025 – New Delhi
During Iphex 2025, our team engaged in insightful discussions and strategic networking with international partners. We highlighted Adaptis’ expertise in Pharmacovigilance and Regulatory Affairs, demonstrating how we empower organizations to achieve regulatory compliance, foster innovation, and drive sustainable growth across global markets.
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