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:-
- Clinical trial applications
- Pharmaceutical, Medical and surgical devices
- Life cycle management
- Active Pharmaceutical Ingredient
- Registration of overseas companies
- Diagnostic kits
- Approval of new drugs
- Approval of formulations
- Indian Discoveries – Phase – I
A. Phase – II
B. Phase – III
C. Phase – IV
Pharmacovigilance & Safety reporting
Regulatory
Frame Works 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
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 Development, 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
