Regulatory Submission

Regulatory Submission Team Helps Adhere to Budgetary Parameters

At Lotus Labs, we understand the imperative for expediting drug development programs so as to adhere to established milestones and budgetary parameters. The Regulatory Submission teams at Lotus Labs are committed to ensuring best-in-class regulatory services that draw deeply from our wide experience in regulatory affairs. Sound knowledge of regulatory requirements, international norms and vast experience of interacting with renowned global regulatory bodies enable us to ensure quality and reliable compliance with regards to steady regulatory submissions. The regulatory submission activities include formulation of regulatory strategies, Compilation of the clinical trial application, Submission and follow-up of the application, Response to regulatory agency queries, procurement of NOC for study conduct and drug import licenses, procurement of NOC for export of biological samples as required by the sponsors/study scope.

Studies conducted at Lotus Labs have been submitted to various regulatory bodies which include:

• The Drugs Controller General of India, USFDA, EMA, ANSM (France), WHO, AGES (Austria), ANVISA (Brazil), MCC (South Africa), FDA (Saudi), MOH Turkey, MCC Zimbabwe, Saudi FDA and NPCB Malaysia
  

• Lotus Labs has been approved for submission of studies to MoH Sudan and MoH Israel

• Studies have been submitted to more than 45 countries

• Over 1100 studies have been submitted to EU and USFDA

• Over 700 studies have been approved by USFDA

• Experience in conducting Phase I - III studies for Biologicals, Neutraceuticals and for other therapeutic areas including Oncology, Cardiology, Diabetes, Dermatology, Infectious Diseases and Anti-retrovirals

• Report submissions have been made in specific regulatory formats for USFDA, Swiss, Health Canada, TGA, EU, China FDA, WHO and others