The “ Operon Strategist” is working towards the catalyzing and ensuring the strategic development of the clients in the areas of Regulatory approvals, Quality Assurance, Quality Control, Licensing and Marketing authorization for the Medical Devices industry, Pharmaceuticals, R and D centers, CRO ’ s, Laboratories and Hospitals. We undertake turn key projects, annual regulatory contract as well as functions on the customized packages as per the need of the client.

The Company is owned and supported by the renowned professional ’ s from different fields of expertise. We owe the people who have high experience and expertise in relevant fields at the national and international level. The company has got all the talents to take up the challenging projects which require high technical expertise and experience. On basis of our long term, committed and ethical services, the international professionals and business houses are attracted to us for the business relations in terms of associates and Partners. We have Branch offices at India, Ireland and China.

Why we? 1.We are working on basis of the committed, time bound and ethical services. 2.We are committed all the times for the services which provide to our customers even after completion of project. 3. All the customers we have, consider us as a trusted, long term and one point solution for all of their needs..

We are committed and bound within ourselves to provide Best Quality service Time bound service Services as committed. service in Reasonable price

We obtain this by: Professional approach Ethical approach Result oriented approach Following commitment. Maintaining confidentiality Teamwork Taking ownership Provide the adequate training to groups and to the extent of individuals.

Facility Set up We Guide and Assist in Facility set up of Medical devices, Pharmaceuticals, Laboratories and Hospitals to the requirement of the National and International regulatory norms. The activity includes the activities almost stating from Land selection to the regulatory liasoning like Local CDSCO and to the extent of international regulatory liasoning like USFDA,MHRA, NABH, NABL as applicable.

Regulatory and QMS Medical Device Industry : 1. Medical devices 510 ( k) submission and Establishment registration 2. CE marking 3. ISO 9001: 2008: Quality Management System – Requirements 4. ISO 13485: 2003: Medical Devices – Quality Management system. 5. USFDA 21 CFR Part 820: Quality System Regulation 6. CAPA Management system 7. Change Management system 8. Liasoning, Audit compliance and related documentation : ISO 9001 : 2008, ISO 13485: 2003, CE marking, 510 (k), CDSCO.

Regulatory and QMS Pharmaceuticals : Documentation: DMF Preparation and Submission. ANDA Preparation in CTD format. Gap analysis, implementation,Compliances and audit preparation of : USFDA, CDSCO, MHRA, USFDA, TGA, EU-GMP

Regulatory, QMS, Accreditation and Certifications Laboratory, CRO’s and R & D centers : Facility set up NABL accreditation ISO 9001: 2008 DSIR approval.

Regulatory, QMS, Accreditation and Certifications Hospitals : OT Set up NABH accreditation ISO 9001: 2008 Microbiological monitoring Infection control

TRAINING ISO 9001: 2008: Quality Management System – Requirements ISO 13485: 2003: Medical Devices – Quality Management system USFDA 21 CFR Part 820: Quality System Regulation USFDA 21 CFR Part 211: Current Good Manufacturing practice Equipment and Utilities Validations Cleaning Validation Microbiological Validations Infection Control CAPA Management system Change Management system

Equipment and Utilities validations Equipment validations: Utilities validations Microbiological Validations Process Validations Cleaning Validation: Analytical method validation

Confidentiality Statement We obtain and collect data from various organisations which may or may not be confidential in nature. As a policy of our company we are bound to maintain all the data and at times name of the organisations for which we work as confidential information.

Our Offices India Operon Strategist Office-7. “ A” tower, Sagar Complex, Kasarwadi, Pune – Maharashtra, India Contact : +91 (020) , China Room 1912, Building No. 1, Hesheng Qilin She, Chaoyang District, Beijing , P.R.China. Ireland Tyone, Nenagh, Co.Tipperary, Ireland.