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GMP Flyer

GMP Pharma Consultants offers a range of engineering, regulatory, production, quality, and compliance services to the pharmaceutical industry. Their expertise includes process development, technology transfer, project management, regulatory strategy, production of APIs and medical devices, quality system implementation and auditing, and validation. Their goal is to provide a one-stop solution to small and medium enterprises for setting up compliant manufacturing facilities and supporting regulatory requirements.

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Santosh Kumar Tata
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173 views2 pages

GMP Flyer

GMP Pharma Consultants offers a range of engineering, regulatory, production, quality, and compliance services to the pharmaceutical industry. Their expertise includes process development, technology transfer, project management, regulatory strategy, production of APIs and medical devices, quality system implementation and auditing, and validation. Their goal is to provide a one-stop solution to small and medium enterprises for setting up compliant manufacturing facilities and supporting regulatory requirements.

Uploaded by

Santosh Kumar Tata
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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GMP PHARMA CONSULTANTS

Offer – Process Engineering

Engineering support for process development, industrialization & transfer of new facilities or revamping,
covering equipment, utilities, instrumentation, automation & control systems with expertise in all
pharmaceutical forms and medical devices.

E X P E RTIS E & S OL UTIO N S


PRODUCT, PROCESS & INVESTMENT PROJECT QUALIFICATION &
TECH TRANSFER MANAGEMENT VALIDATION
• Scaling up • Feasibility studies/URB, conceptual • Process
• Technology transfer design / URS, basic / detailed • Equipment & Utilities
• Decommissioning design • Computer Systems
• Optimization • Vendor Management, construction • Cleaning
and site supervision, commissioning • Calibration & Measurement
/ qualification
• Hand Over & Performance follow-up

Offer – Regulatory Affairs

Project management and operational support for product registration and life-cycle management with respect to
local regulations. Adapt to evolving regulation and ensure that requirements are respected and maintained
without impacting operations and time to market.

E X P E RTIS E & S OL UTIO N S

REGULATORY STRATEGY

• Definition and follow-up of the world-wide regulatory strategy


• Contact with health authorities supplying answers to questions
• Permanent regulatory watch, training and remediation plan

Offer –PRODUCTION
• Intermediates & APIs
• Ayurvedic products
• Excipients
• Packaging materials
• Medical devices
• Homeopathic products
• Formulations (sterile and non-sterile)
Formulation support for OTC products,
Nutraceuticals/Dietary supplements/Functional foods and
Cosmeceuticals

Offer- BIOTECHNOLOGY APPLICATIONS


• Genotyping-biochemical / molecular makers
• Enzymatic transformation-Value added products
• Microbial production-industrial enzymes
• Nutra ingredients
• Diagnostic enzymes
Offer-AGRICULTURE RESERACH
• Crop analytics
• Seed/grain quality
• Food/Nutritional quality

Offer – Quality & Compliance


One stop solution to the small and medium pharmaceutical and food enterprises for all
their needs in setting up factory in terms of-

Compliant quality systems deployment & optimization, adapted to business needs and site specificities,
regulatory upgrades, supporting the whole life cycle for pharma (GLP, GCP, GCLP & GMP) and medical
devices (21 CFR 211, 820, 210 and ISO 13485 &14971).

• Planning and executing the project


• Establishment of the GMP& GLP, ISO & HACCP systems
• Project Management
• Third party audits on behalf of clients in India and abroad
• Implementing quality systems
• Compliance Audits
• Dossier Preparations
• Getting certificate as per various regulatory norms
• Comprehensive Training
• Validations
• Answer all queries from regulatory authorities

E X P E RTIS E & S OL UTIO N S

QUALITY MANAGEMENT OPERATIONAL QUALITY QUALITY CONTROL


SYSTEMS ASSURANCE
• Compliance strategy, audit • Document management • Method development and
and remediation training validation
management • Change control, PQR • Analytical method transfer
• QMS implementation, • CAPA and deviation • Laboratory equipment
optimization and • Periodic Review (process) qualification
maintenance • Qualification and validation • Stability study
• Customer complaint
handling

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