GMP AND REGULATORY

CONSULTING SERVICES

FOR DESIGN COMMISSIONING OF PLANT
Explore Our Services

QMS ESTABLISHMENT

AND REGULATORY APPROVALS

Comprehensive Quality Management Solutions
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About Us

SPM Pharma-Tech is a GMP and Regulatory Consultancy Services company based in Mumbai, India.

We specialize in GMP compliance and regulatory affairs, offering a comprehensive range of services including GMP compliance consulting, qualification and validation, regulatory submissions, engineering and design consulting, plant design services, and specialized training programs.

Our team of professionals brings over 20+ years of combined experience in the pharmaceutical industry, serving clients across domestic and international markets. We have successfully worked with companies ranging from small and mid-sized enterprises to large multinational corporations.

We help drug manufacturing companies achieve necessary regulatory approvals for their operations. Our expertise is particularly valuable for businesses that hold marketing licenses but require EU GMP approved manufacturing facilities to supply their drug products to international markets.

We value client satisfaction, integrity, honesty and confidentiality of data.
20+ Years

Experience in pharmaceutical industry

Global Reach

Domestic and international markets

Trusted Partner

Client satisfaction, integrity, and confidentiality

Our Achievements

Our track record speaks for itself. We've successfully guided numerous clients through complex regulatory processes across multiple markets and dosage forms.

23+

Client Regulatory Inspections

Successfully Achieved

12+

Dosage Forms Successfully Qualified
Tablets
Capsules
Pellets
Ointments
Creams
Liquid Oral
Liquid Injection
Dry Powder for Injection
Sachets
API
External Preparation
Lyophilised Products

5+

Regulatory Authorities Successfully Engaged
EU GMP - Greece Authority
EU GMP - Hungary Authority
EU GMP - MHRA Authority
EU GMP - Portugal (INFARMED)
EU GMP - Croatia Authority

Training Programs

Comprehensive training solutions designed to enhance your team's expertise in pharmaceutical operations

1
Industrial Training for Fresher Candidates

We are involved in various Industrial Training Programs and Placement Services. We can help you train for your job whether you are graduate/post-graduate with Science or Commerce/Arts background.

Placement Services
All Backgrounds
2
Industrial Training for Aseptic Practices

This two-week comprehensive training program is taught by industry-leading experts with over 15 years of combined experience. It will give you training and information needed to properly evaluate and improve your aseptic processes.

2 Weeks
Expert Led

Our Team

Meet our experienced directors who bring decades of expertise in GMP compliance, regulatory affairs, and pharmaceutical operations.

Manoj Dubey
Director
20+ years
Experience
40+
Clients
100+
Products

Manoj has 20+ years of Regulatory and GMP experience in pharmaceutical industry in various dosage forms including Parenteral, Solid oral, Liquid Oral, Effervescent, Oncology, Cephalosporin, Penicillin, Suppositories, Soft Gelatine Capsule, External preparation, Sterile Ophthalmic etc. He is a Pharmacy Graduate who has managed projects, plant designing, commissioning, execution, validation, team building and imparting technical knowledge within the team and industry. He has worked in various renowned MNCs such as Mylan, Cipla, Mission Vivacare, Macleod Pharmaceuticals, Maneesh Pharma, Celogen Life science & Technologies, Prosfora Technologies and has handled more than 40 clients in previous organisations. His diversified experience in various pharmaceutical industry operations has helped contribute significantly to all employers.

Previous Organizations
Mylan
Cipla
Mission Vivacare
Macleod Pharmaceuticals
Subhash Parkhey
Director
20+ years
Experience
40+
Clients
100+
Products

Subhash has 20+ years of Regulatory and GMP experience in pharmaceutical industry in various dosage form including Parenteral, Solid oral, Liquid Oral, Effervescent, Oncology, Cephalosporin, Penicillin, Suppositories, Soft Gelatine Capsule, External preparation, Sterile Ophthalmic etc. He has worked with various renowned companies in India and abroad such as Ethypharm, Alkem Laboratories, Syncom Formulation, Celogen Life Science & Technologies, Prosfora Technologies. He has also handled more than 40 clients, more than 100 products filling for EU markets and 5 ANDA filling for US Markets. His approach is client satisfaction, knowledge up gradation, integrity, honesty and confidentiality of data.

Previous Organizations
Ethypharm
Alkem Laboratories
Syncom Formulation
Celogen Life Science