Welcome to Medi Tree India

Email : business@meditreeindia.com
  Contact : 1800 - 274 - 4732

Regulatory Affairs Service

Regulatory affairs provide an overview of drug/ Device development across the value chain of a product. Regulatory Affairs Maps the drug/Device right from the development to clinical trials to post marketing surevellence. It serves as a primary link between the company and the regulatory authorities.

Meditree is one of the most comprehensive regulatory affairs compliance consultants based in India. Meditree offer comprehensive pharmaceutical regulatory affairs services to meet all kinds of challenges in Pharmaceuticals, Medical Devices, Bio technology, Diagnostic and CRO industries.

At Meditree we have, In depth knowledge of various law, Competent work forces, regulatory frame work of India and global markets, competence on creating an acceptable dossier and maintaining time lines of submission and achieving approval

SERVICES OFFERED BY MEDITREE :-

  1. Clinical trial applications
  2. Pharmaceutical, Medical and surgical devices
  3. Life cycle management
  4. Active Pharmaceutical Ingredient
  5. Registration of overseas companies
  6. Diagnostic kits
  7. Approval of new drugs
  8. Approval of formulations
  9. Indian Discoveries – Phase – I

A. Phase – II

B. Phase – III

C. Phase – IV

  1. Pharmacovigilance & Safety reporting

REGULATORY FRAME WORK IN INDIA :

  • Central drugs standard control organization.
  • Drug controller general of India.
  • Drugs price control orders – National pharmaceutical pricing authority(NPPA)
  • The drug & Cosmetics ACT 1940
  • The Pharmacy Act -1948

ADVISORY SERVICES OFFERED ON GMP DOCUMENTATION

Preparation of quality manual and Policy for the company

  • Preparation and revision of Site Master File
  • Preparation and revision of Validation master Plan
  • Protocols for DQ, IQ, PQ and OQ for equipments
  • Process Validation
  • Analytical validation
  • Cleaning validation
  • Mock audit for country specific compliance
    Writing of QA, QC, Production, R&D and Corporate QA SOP’s
  • Review and revision of existing SOP’s
  • Preparation and review of packaging material and raw material specifications
  • Preparation of Safety, health and environment related SOP’s
  • Review existing MFR’s and revise to meet regulatory requirements
  • Preparation of annual product review and trend analysis
  • Review and revision of protocols for various types of validation
  • Product Develoment, analytical development & Stability services
  • BA & BE Studies
  • Other GMP documents
  • Review of documents and approvals from regulatory agencies to identify gaps and non compliances AUDITS
  • We conduct comprehensive audits as per the requirements of GMP auditing, ISO, UK-MHRA, MCC, TGA, in house or other standards as required by you.
  • Training on GMP, SOP and strategy to face audits

For any assistance please Contact Us