The Operon Strategist provides regulatory, quality assurance, and marketing authorization services for medical devices, pharmaceuticals, research and development centers, contract research organizations, laboratories, and hospitals. It assists with facility setup, quality management systems, accreditations, certifications, and training. The company owns branches in India, Ireland, and China, and aims to deliver high-quality, timely, and cost-effective services with a commitment to confidentiality and compliance with international regulatory standards.

2. 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.

3. 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.

4. 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.
.

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

6. 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.


7. 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.

8. 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.

9. 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

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

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

12. 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

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

14. 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.

15. Our Offices
India
Operon Strategist
Office-7. “ A” tower,
Sagar Complex,
Kasarwadi, Pune – 411034.
Maharashtra, India
E-mail: anil@operonstrategist.com
Contact : +91 (020)46780055, +91 9823283428.
China
Ireland
Room 1912, Building No. 1,
Hesheng Qilin She, Chaoyang
District,
Beijing 100102, P.R.China.
Tyone, Nenagh,
Co.Tipperary,
Ireland.