Regulatory Submissions

Gratisol Labs clinical trials regulatory affairs experts allow us to offer clients personalized regulatory submissions from locations worldwide.

Regulatory affairs in another core service area within Gratisol Labs. Regulatory experts and full-time translators throughout our global presence allow personalized regulatory submission and follow-up for all our clients. Clinical trials regulatory affairs expertise will make all the difference when submitting your clinical trial for approval.

  • Regulatory affairs services include:
  • Preparing and filing clinical trial applications using dedicated regulatory staff
  • Worldwide regulatory affairs knowledge and coverage
  • Compiling IMPDs
  • Translating and back-translating clinical trials applications into multiple languages
  • Procurement of local patient insurance
  • Advise on correct labeling of immediate and outer packaging
  • Obtaining import licenses for investigational products, ancillary supplies and equipment
  • Acquiring export licenses for biological samples and re-export licenses for returnable equipment
Home Services Regulatory Submissions

Connect with us


KVR Enclave, 2nd Floor, 207, Gurudwara Lane,
Beside Satyam Theater, Above ICICI Bank,
Ameerpet, Hyderabad– 500016,
Cell: +91 9705790302 / +91 8885198390