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Regulatory Support

Regulatory Support

Bringing a new product from laboratory development to marketing approval is a lengthy and very expensive process. If any delays occur because of the regulatory issues could seriously cost the innovator in money and time.

Innovate Research Pvt. Ltd., is provides seamless, transparent and current good regulatory consulting services to clients across Pharmaceutical, Biotechnology, and API manufacture, Finished Formulations Manufacture, Medical Device, Food and Beverage companies.

Our approach is very simple. We understand each of our client’s needs in-depth and we analyze their regulatory needs. With advance planning and strong and stringent execution of regulatory filings in compliance with respective regulatory agencies, we provide global current regulatory support to our clients ahead of the time.

Our services range from a simple advisory service consulting to full IND, NDA and IDE preparation and submission, including submissions in electronic Common Technical Document (eCTD) format.

Highly experienced and broad knowledge Katalyst’s team members, including Clinical, Medical Safety, Data Management, Statistics and Project Management, are available to assist as single or as a completely manageable fully functional clinical development team to ensure successful product registration in American, European and all other global markets.

Innovate Research offers wide range of Regulatory Services:
  • Regulatory affairs: CMC, Dossiers
  • Regulatory Strategy and Intelligence from Molecule to Market.
  • Regulatory Submissions: IND, NDA, ANDA, BLA and CTA applications (Paper & eCTD)
  • Regulatory Writing: Clinical and CMC
  • Regulatory support for Clinical Trials
  • Regulatory Operations: Clinical and Non-Clinical Publishing and Submission.
  • Regulatory Labelling: Clinical and Non-Clinical
  • Regulatory Agency Liaising
  • Regulatory Business and Outsourcing Consultancy

Services

Study Feasibility

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Medical Writing

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Regulatory Support

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Clinical Monitoring

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Project Management

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Data Management

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Biostatistics Services

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Biospecimen Collection

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Insourcing & Outsourcing

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IWRS services

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Site Management

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