2. Index
Introduction
Our Group Companies
Cyclone India Group companies
Our mission
Cyclone Pharmaceutical Pvt. Ltd.
• Introduction
• Our prime services
Cyclone pharmaceutical consultants
• Introduction
• Our services
• Our expertise
• Infrastructure
• R & D Analytical set up
Pharma QA
• Introduction
•Our prime services
How we work
Team cyclone
One stop solution
Future vision
Summary
Visit us
Contact us
5. 1
• Cyclone Pharmaceutical Pvt. Ltd.
2
• Cyclone pharmaceutical consultants
3
• Pharma QA….. Leading Pharmaceutical Consultants
4
• Cyclone Ayurvedic and Herbal division
5
• Educational and trainings - QERC
6
• Cyclone India Essences
7
• BR life science
8
• Swaraj services
9
• Social activities- Rudra Foundation
6. Service for cGMP & DMF.
Continuous Up-gradation of cGMP System.
Mutually beneficial Professional Partnership with the Valued
Customers.
Value Addition towards Regulatory understanding and
Compliance.
Training via Creative and Innovative ways.
9. Regulatory
Formulation
Prime Services1. DMF compilation
Prime services-
2. Dossier compilation
1. New formulation
development
3. ACTD & CTD Dossier
5. NDA/ANDA
2. Established database
of about 10000
different formulations
6. Excipient DMF
3. Technology Transfer
7. Dossier for Herbal and
neutraceutical
4. Method Transfer
4. CTD for Russia
5. Formula verification
8. Variance Filling
Supportive Services –
BA/BE study, Clinical trials,
Pharmacovigilance, Pharmacological
services, Analyical Services, Stability
Services
Supportive servicesProcess validation, Analytical
method validation,
Volumetric solution
validation, TLC method
validatio n
10. DMF compilation as per country norms for API, Excipient, Colourants and
packing materials
CTD, ACTD, eCTD and all other country Specific Dossiers and DMF
compilation for Pharma Products.
Expertise in Compilation of dossier for Philippine, Vietnam, Cambodia,
Myanmar and for all Asian Countries.
Dossier Compilation for Latin American, South African, Russian, CIS and
Other Countries.
Dossier Preparation for Nutraceuticals, Ayurvedic Medicines and veterinary
Products.
Other regulatory services
11. Huge database of Formulations and API.
Having well experienced 15 technocrates working
with CPPL
Dedicated Senior R & D, QA, QC Experts
Around 5000 Specifications and STP’s are ready with
us.
Having Experience of compiling more than 2000
Dossiers.
Association with expert from each sector of pharma
profession
12. Tie up with well equipped R &D and analytical
laboratories with following support1. Development facility for tablet , capsules,
liquid and other dosage form
2. Supporting analytical laboratory with HPLC,
HPTLC, TLC, GC, IR, Dissolution Mass Spectra
assemblies.
14. Pharma QA is established in the year 2010 as a part of Cyclone India
Group.
Pharma QA is known as Best GMP Consultant of India. Pharma QA
provides most economic & highest quality services for Pharma industry.
Pharma QA has implemented ‘Quality Integration Project and
Pharmaceutical Inspection Convention Services’ first time in the world
which provides a integrated quality solution for all your quality needs and
gives financial, technical and quality relief to small and middle scale
Pharma manufacturer. Pharma QA itself acts as your virtual QA
department.
15. Quality integration project:
Virtual QA department
• Complete GMP,
regulatory and
production management
establishment
• Operational cost
reduction
• Disciplined quality system
which can qualify for
audit of the the world
• Minimum document and
simplified system
• High quality training to
staff and worker
• Prompt and timely
deliveries of materials
with a quality parameters
• GMP documentation
services
• Audits and QA moitoring
• QP (quality pharmacist
service
Validation project
• Equipment validation
• Facility validation
• AHU/HVAC validation
• Water system validation
• Utility validation
Audit services
• New plant audit
• Contract manufacturing
audit
• Regulatory, WHO, MHRA
pre-audit
• Internal audit (self
inspection)
• Vendor audit
• Consignment audit
• QA and documentation
audit
• Energy audit
• API plant quality system
audit
• Assistance to overseas
client to monitor quality
Training
• On the job GMP training
• QA & Quality system
training
• Audit Training
• Technical Training
• Refresher Training
16. We work with harmony with the customers and FDA.
We focus on Current Regulatory Requirements
We assure value additions to the system.
We provide backup as and when required.
We help the customer to meet all the Queries.
To be continued……….
16
17. We monitor Regulations and the "Regulators" on a
routine basis.
We sort through the Details, Interpret the Events
and determine the right course of action for your
organization.
We work with you at a level of Mutual Trust and
Satisfaction.
17
18. Team cyclone build by Expert Technocrats of Indian Pharma
Industry having more than 15 years of Quality ExperienceOur consultants........
1. Sachin Bhalekar , B. Pharm, MBA
2.
3.
4.
5.
6.
Sandip Ghule , B. Pharm, MBA
Kumudini Phapale , M.Sc.(Biotechnology)
Avanti Rao, M. Pharm. (QA)
Rohit Shinde, (R & D Scientist)
Dr. Amol Shah, M. Pharm., Ph. D.
19. We provide practical solutions to the Regulatory
Problems related to cGMP / Validation / DMF.
We Provide Quality Service
We Meet the Time Frames.
20. To be world’s best pharmaceutical
GMP consultants
To serve Pharmaceutical Industry
with innovative Idea.
21. CYCLONE INDIA GROUP is a Young, Dynamic
company with a clear knowledge of GMP.
It has Customer Satisfaction and Customer Retention
as key measurable.
It has a reputation built on Quality, Reliability,
Responsiveness and Timely Services.
It delivers cost-effective Services/Solutions in
Regulatory, GMP, quality management, audit,
training, manufacturing and marketing.
