REGULATORY AFFAIRS

Regulatory affairs, nowadays, are becoming complex, and to be in a position, we need to provide apt regulatory solutions and stay ahead of changing requirements in the global clinical research industry. Raptim Regulatory team can help you build a regulatory strategy, develop global clinical and regulatory plans, and execute them on your marketed product registration requirements so you can focus on research and development.

Regulatory Affairs are a fundamental component of our services portfolio. Our team works hard to maintain high quality and strict adherence to the applicable standard(s) and guidelines like ICH, FDA, EMA, Clinical, and Bio-Analytical. Throughout your drug development lifecycle, we can help you navigate complex regulatory requirements. Our Scientific and Regulatory Affairs team participates in regulatory decisions to ensure that your study meets the requirements of the appropriate authorities.

We recognize the importance of having up-to-date knowledge of the latest regulations and guidelines to provide the best consultation service with dedicated and effective liaising with various regulatory agencies that ensure higher success ratio in the Clinical Trial approval process. We have immediate access to key areas of expertise such as medical expertise, statistics, pharmacy, project management, bio analysis, and quality assurance. We work closely with our clients to ensure that regulatory submissions are produced in accordance with the milestones and milestones of clinical trials. Raptim continually reviews and assesses the best approach reflecting the current requirements.

Raptim regulatory services included but not limited to:

  • To achieve the regulatory goal, we can suggest a concrete regulatory strategy to give you a competitive advantage
  • Provide detailed feasibility before study execution to get real-time information and expected timelines.
  • Preparation & submission of regulatory documents for obtaining:
    • Approval to conduct a clinical trial in India
    • Approval to import Investigational Products
    • Central Bureau of Narcotics (CBN) and State FDA permit to import Narcotic and Psychotropic substances
    • Liaising and Obtaining registration documents in the interest of clients
    • Continuous follow-up post submission with regulatory authorities
    • Safety reporting
  • Preparation of regulatory submissions in CTD and eCTD format
  • Preparation of summaries required for generic submission
  • Executing regulatory submission
  • Responding to the health authorities’ queries during the approval phases of the product
Regulatory offerings in Raptim have successfully completed over 30+ regulatory inspections from Indian & International Regulatory agencies and 70+ sponsor audits from Indian and International clients. All the services are executed in strict compliance with regulatory and ICH GCP requirements.

Raptim’s Regulatory Track Record

  • 24 Times (2020)
  • 2 Times (2021)
  • 2 Times (2020)
  • 11 Times (2021)
  • 3 Times (2019)
  • 1 Time (2015)
  • 1 Time (2019)
  • 1 Time (2019)
  • 1 Time (2019)
  • 1 Time (2021)
Authority No. of Inspections Latest Done On
USFDA 24 February, 2020
NPRA, Malaysia 01 October, 2019
UK MHRA 02 May, 2021
WHO 02 July, 2020
BfArM, Germany 01 July, 2019
HPRA 01 July, 2019
CHILE ISP 01 May, 2015
INDIAN Regulatory 11 August, 2021
NABL 03 May, 2019
Anvisa 01 August, 2021

Clinical Trials Site Audit History

Therapeutic Indication Regulatory Body Inspection date (s) Inspection area
GIST/Advanced RCC USFDA 05 Nov 2020 to 30 November 2020 GCP Audit
GIST/Advanced RCC USFDA 10 Nov 2020 to 01 December 2020 GCP Audit
GIST/Advanced RCC USFDA 06 Nov 2020 to 02 December 2020 GCP Audit
Chronic myeloid leukemia/GIST USFDA 16-20 September 2019 GCP Audit
Chronic myeloid leukemia/GIST USFDA 23-27 September 2019 GCP Audit
Epilepsy USFDA 11 July 2016 to 11 October 2016 GCP Audit
Epilepsy USFDA 28 December 2016 to 30 December 2016 GCP Audit
Epilepsy USFDA 11 February 2016 to 11 April 2016 GCP Audit
Epilepsy USFDA 21 November 2016 to 26 November 2016 GCP Audit

Raptim readiness to face the continuous regulatory audits:

Audits can trigger at any time and we need to be ready to act during any such event. We, at Raptim, believe that audit readiness is more than a “One Time” event. Raptim’s Regulatory Services reaches the drug development planning of sponsor in hand with the regulatory strategy and development plan helps eliminate surprises, keep development on track, and ensure appropriate quality strategy at each step of the services.

We ensure following to meet this goal:

  • To perform study-related activities, highly trained Staff is available. Training is ensured by experienced staff/senior before delegating any study-related activities
  • All study-related documents are promptly filed in the Trial Master files (TMF’s) and ensured that all these documents are complete with all relevant details
  • Continuous verification of the systems and documents ensures facility readiness at any given point of time
  • We ensure compliance to study protocol requirements. Our in-house quality monitoring team conducts reviews of documents and processes throughout the study
  • In-house Quality Assurance team conducts audits of equipment and system/facility periodically. This helps to keep a check on the compliance with in house procedures. To verify the compliance with study protocols, study audits are conducted
  • Senior Management continuously monitors the quality systems of various departments to ensure that all standard processes and practices are implemented, thereby ensuring all time audit readiness of various facilities