Savitribai Phule Pune University

KTHM

Founder and CEO @ Medical Device regulatory and Turnkey Project Consultant | Operon strategist

Medical Device Turnkey Project Consultant:
The Company is working towards catalyzing the Strategic Development of the Clients in the regulatory and quality assurance field for the medical devices, Pharmaceuticals, R and D centers, Food industry and the Laboratories.

The strategic development steps and stages include but not limited to the Layout planning of the set up's, Equipment and utility validations, Process validations, Obtaining the regulatory approvals like Local FDA, EUGMP, MHRA, USFDA, 510 (k), Establishment registration and Device Listing etc, Gap analysis, Registration of the products in countries, Obtaining the credentials like ISO 9001,ISO 13485 and obtaining CE. etc. are our activities.

We Have Successfully Handled 60+projects Related to Medical Device Manufacturing Industry and 30+ projects are the Turnkey projects By including Layout Design, Clean Room Design, Facility Plant setup Design & Process validation.

Our Service sector Presence in The global Network and 60+ Happy clients in the Worldwide.
Regulatory experience in medical device Manufacturing industry /Primary Packaging Industry.

We provide Regulatory Consultant Service  For ISO 9001, ISO 13485, We Successfully handled Regulatory Project For CE Marking, USFDA, USFDA 510(k),21 CFR Part 820,  CDSCO, FDA, GMP, ANVISA, TGA, and client audits towards GMP certification & product registration.

Efficient and effective relationship management With the client , communication skills with ability to lead & key influencers role in regulatory affairs, regulatory compliance systems, audits and quality assurance.

Our Company Specialties:
Regulatory Strategy, Regulatory Affairs, Regulatory Operations, Regulatory Compliance, Audits & Compliance, Quality Assurance, Qualification/Validation , quality management system compliance , turnkey services ,  system implementation , manufacturing unit , Medical Device Design And Development , training, licensing, regulatory approvals and certifications

Operon Strategist | Medical Device Consultancy, 510 k Consultancy, Turnkey Project Consultant

Founder and CEO | Medical Device Consultant | USFDA consultant | ISO 13485 Consultant

Key Working Areas:
*Responsible for all QA activities.
*Responsible for the implementation and documentation of IQ, OQ, Performance qualification and routine performance qualification of the manufacturing equipment (Vial, Pre-filled syringes, and Ampoule line), QC equipment and utilities (Water system, HVAC system etc). 
*Responsible for implementation and documentation Media fill, process validation, Cleaning validation, Container closure integrity validation, Microbiological validations etc.
*Direct co ordination with the contract giver (Pfizer, BMS, Sandoz etc) for the QA activities, tech transfers, and their implementation.
*Responsible for Review of documents with respect to ANDA submission.
*Compliance of the Micro deficiencies.
*Compliance with the regulatory and customer audits.
*Audit compliance for external audits (Regulatory and Nonregulatory).
*Handling of change controls, deviations, incidence, CAPA, OOS etc.
*Handling of the External Audits (Regulatory and Customer).
*Handling of the Vendor approvals. 
*Handling of the Self-inspection.
*Handling of MRM’s.
*Handling of the Microbiology department with respect to the audit compliance.

Emcure Pharmaceuticals Limited

MANAGER: QA and QC

Key Working Areas:
• Handling all ISO and CE related activities.
• Handling of Change controls, Deviations, SOP’s, Specifications etc.
• Conducting internal audits.
• Looking after Microbiological testing.
•	Equipment and classified area qualification.
•	Preparation of SOP’s and  Specifications

Anil Chaudhari