CALL : + 91 9881145403
Menu

Services

Home » Services

We Offer;

Regulatory Services :

  1. Regulatory Strategy : For various markets like the US, UK, EU, Canada, Australia, SA, Newzeland and ROW, etc.
  2. Regulatory Submissions for Drugs: Which includes dossier preparation, Module 1 to 5 (Pre-IND, IND, ANDA, MAA, ANDS etc) and DMF preparation, review and submission to various Regulatory Authorities in eCTD, customized support on particular Modules can be provided.
  3. Regulatory Submissions for Medical Devices: 510k submissions, CE Tech file preparation and submission as per latest MDR requirements.
  4. Gap Analysis : Due diligence of the dossiers, DMF, and API supplier evaluation.
  5. Publication : Can provide services for eCTD publication.
  6. Undertake management of query response to Health Authorities.
  7. Life Cycle Management support for renewal, Annual report, Variation submissions, CEP monitoring, GMP status monitoring.
  8. Labeling management : PIL, SmPC, preparation, SmPC and PIL updates, bridging study and User testing in EU and RLD identification.
  9. Drugs import license for testing and analysis purpose (form11) /India
  10. Import license and registration certificate for import of drugs (form 10 & RC in form41) /India
  11. New drugs Approval for import and market. (form 45)
  12. New drugs Approval for manufacturing & market for drugs, biological products and medical devices (form 46)
  13. Import license and RC for medical devices in India
  14. Biological-MA, CT NOC, NDA in form 45 ,46 and 28D for sale and distribution of vaccine ,blood products and sera, Test license in form 11 for CT
  15. New drugs-CT NOC,BE NOC for domestic purpose, new drug approval in form 45,46 test licenses

GMP Services :

  1. Help in arranging the API Manufacturing site audit by the UK/EU QP
  2. Help in arranging the FP manufacturing site audit by UK/EU QP
  3. Site Gap Analysis and preparedness for various GMP inspections like EU/UK/SA/NZ/AUS/PICs etc.
  4. Triggering of the EU/PICs GMP inspection.

Clinical Research :

  1. BA/BE study design strategy, protocol preparation, and Review.
  2. Identification of CRO
  3. Commercial negotiation with CRO and contractual arrangement with CRO
  4. CRO Audit
  5. Identification of Suitable Reference Product for BE study.
  6. Monitoring of BA/BE study
  7. Review of BA/BE report and preparation of Module 2.4/2.7/4 and 5
  8. Literature Screening
  9. Medical writing like Non-Clinical Overview, Clinical Overview.
  10. Bio-waiver strategy.

Pharmacovigilance :

  1. Setting-up and managing the Pharmacovigilance activities
  2. Can help in Handling of various EMEA Referral procedures like article 30 and 31.
    • PSUA procedures
    • RMP writing
    • PSMF Preparation
    • SDEA
    • Safety Variations

Strategic Alliance and Business Development :

  1. Helps in finding out partners for development, manufacturing, BA/BE CROs, Clinical Trails and Pharmacovigilance service providers.
  2. Assist in acquisition & divestment of MAs/ANDAs,

GVP and GCP Auditing :

  1. Undertake GCP and GVP auditing by the qualified auditors.