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Regulatory Services

With constant changes in regulations and guidelines, the launching of drugs in multiple countries, and mounting competition, pharmaceutical, biotechnology, and medical device companies are finding it increasingly difficult to manage their submission activities. Although most life sciences organizations have stringent practices in place, maintaining the licenses of approved products and bringing new products to market faster have become even more challenging.  Regulatory operations groups within these organizations are looking for ways to reduce costs and turnaround time for their regulatory submissions.

HCL’s Global Delivery Model is the solution for better quality and faster submissions globally. It is a cost-effective approach that offers onsite/near-site SMEs to check the quality of deliverables while outsourcing labor-intensive work to a more economically viable region.

Through its team of professionals with international regulatory expertise, HCL helps ensure that marketed products are fully compliant with regulations at all times and remain on the market, as valid and safe products. HCL’s model also significantly reduces the chances of RTFs. With a trained team and experienced SMEs, HCL can support sponsors with NDA/BLA submissions and maintain marketing approvals globally.

Key Differentiators

  • Better local time zone service and communication
  • Faster turnaround time with quicker submissions
  • Higher quality
  • Improved efficiency, which can reduce costs by as much as  40% to 60%

Services Offered

  • Electronic submission publishing services for marketing authorization applications and post-marketing submissions globally for electronic common technical document (eCTD), non eCTD electronic submissions (NeeS) formats, and paper submissions.
  • New drug applications, investigational new drug submissions, multiple amendments, and supplementary submissions, drug master files, structured product labeling, variations, renewals, safety reporting, and annual reporting across the globe. 
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We will treat any information you submit with us as confidential. Please read our privacy statement for additional information.

We will treat any information you submit with us as confidential. Please read our privacy statement for additional information.