Regulatory
A powerful Regulatory Affairs process automatically takes care of progress, productivity and profits. Our experienced regulatory consultants and compliance professionals provide actionable, effective solutions to complicated research scenarios and product development. We track the ever-changing legal and regulatory landscape to provide current, on-demand regulatory support tailored directly to you.
Regulatory Intelligence
Regulatory Compliance
Regulatory Affairs
Life cycle management
We consult and help setting up regulatory e-systems for companies.
Discovery
Providing solutions for collection, validation, analysis and dissemination of regulatory and statistical data so as to help the professionals focus on the right things
360° Data Analytics
Change Management
Regulatory Strategies
Product Strategies
Product Selection Strategy
360° Data Analytics
Market Intelligence
Competitor Landscape
Regulatory Intelligence & Strategy
Submissions
Regulatory Audit
Pre-submission & Post-Submission (IND, NDA, ANDA, ANADA)
US Regulatory Agent
Worldwide Regulatory submissions
East Asian peninsula (Japan, Korea, China)
Latin American Peninsula (Brazil, Argentina, Mexico)
Europe
North America (US, Canada)
eCTD, ACTD, NeeS submissions
Training
We strongly believe in practical regulatory submissions, which would help the company in achieving, Business Goals, Cost Reduction Initiatives, Regulatory Compliance. It is always essential to keep the requirements in current state. Hence we take up training sessions for teams, on these current requirements which help them to be informative and updated to prepare various regulatory documents, the company would require. We provide training on various topics which include :
Regulatory submissions
KSM Selection
Change management
Global submission
Submission life cycle