Regulatory Affairs:

  • Clinical Study Reports
  • Investigators Brochures
  • Subject Narratives

Regulatory Affairs includes:

The Life Sciences industry is vigorously regulated. Medications could never achieve market without the skill of regulatory experts to guarantee products being developed are meeting worldwide regulatory standards. The Regulatory Affairs' Practice will likely bring simple, functional solutions for client' regulatory issues, and has earned an outstanding notoriety for doing only that. At Genostats we comprehend the significance of appropriately exploring a complex worldwide regulatory field. We have a different global system of regulatory issues experts and specialists accessible to help our clients' advancement lifecycle from preclinical through product endorsement.

Genostats Regulatory Affairs experts will be there to help control you through the additionally developing regulatory atmosphere. Genostats works with its clients giving the proper aptitude at all times. Genostats is very much situated to give high effect regulatory issues proficient or a balanced team, to help convey client-driven arrangements in:

  •   Regulatory Strategy
  •   Regulatory Submission Planning
  •   Prepared and submitted ANDAs and NDAs (counting eCTDs), and DMFs
  •   Chemistry Manufacturing and Controls (CMC)
  •   Product Labeling Development and Strategy
  •   Clinical Trial Authorizations, Maintenance, and Trial Support
  •   Competitive and Regulatory Intelligence
  •   Regulatory Authority Meeting Preparation and Facilitation
  •   Launch and Post-Approval Activities
  •   Prepared FDA meeting requests and imperative instructions bundles for PDUFA meetings

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Medical Writing

Our comprehensive records are peer reviewed and experience a stringent quality assurance to guarantee medical and scientific accuracy.

Validation

The pharmaceutical business is regulated vigorously globally and is continually challenged by regularly advancing stringent directions.

Pharmacovigilance / Drug Safety

In the present pharmaceutical, biopharmaceutical and medical device product scene, you can't bear to miss crucial safety data about your products.

CDISC Advantages

CDISC is the most significant advancement for convenience in data trade without perplexity inside the pharmaceutical business and between the industry and regulatory authorities.

Clinical Data Management

Clinical Data Management We comprehend that high-quality data is significant for the achievement or failure of the clinical trial. Genostats provides Clinical Data Management service.

CLINICAL STAFFING

In the clinical industry, it takes many years and an extraordinary investment to bring a product to license.