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

Discover Our Services

Making sure your Regulatory Needs are catered

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