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Specialized in Consulting and Implementation of
Quality management System
Unikal Consultants, a leading Consulting
organization is an integrated service provider to
the corporate clients.
The Company
specializes in Consulting and Implementation of:
-Quality management System as per ISO 9001, ISO
13485 and CE requirements as per European Council
MDD/93/42 & Audits for Projects of Manufacture of
Sterile Medical Devices
-Documentation & Training for various c-GMP
systems including US-FDA, MCA, TGA requirements.
ISO 9000 & QUALITY MANAGEMENT SYSTEM,CE
CERTIFICATION, US FDA 510k,AUDIT, DOCUMENTATION
AND GMP
Special focus of Unikal's Technical team of
Specialists is providing Consulting Services for
Chemical Technology; ISO 9000 & 13485 Quality
Management System, CE Certification, Audit,
Training, Documentation and for GMP & WHO-GMP, US
FDA Pre-market Notification 510(k) Submissions.
Headquartered at Ahmedabad, Unikal's clients are
placed across the country - Ahmedabad, Ankleshwar,
Cochin, Chennai, Jodhpur, Udaipur, Surat, Mumbai,
Hyderabad, Chandigarh and Delhi.
Foreign clients are in China, USA, UK etc.
Collaborators for EC Services are in Brussels, EU.
Clients include Industries Manufacturing
Products like:
Sterile Single use Medical Devices, Infusion sets,
Catheters & Tubes, Syringes, Intra Ocular Lenses,
IUD, Coronary Stents etc. Engineering Items,
Telecommunications, Electronics.
Active Pharmaceuticals Ingredients (API),
Formulations in Pharma & Ayurvedic Industries.
Unikal Consultants is managed by Mr. Sanjay Y.
Shah in the capacity of Chief Consultant. His
experience in the professional field starts from
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