About Us
About
GXPZONE and LEADERSHIP
GXPZONE is complete product solution provider in the field of pharmaceuticals. The consulting team comprises professionals having rich and extensive experience in product development, world wide Regulatory submission and Quality Assurance.
We offer services in the field of Regulatory submissions, Quality and compliance, Product development and Life Cycle management for developed markets like US, Canada, Europe, Australia, New Zealand to merging markets Asia, Africa, Middle East, Latam, CIS etc. GXPZONE’S services are underpinned by superior quality standards, attention to detail and long standing relationships with our clients.
GXPZONE is dedicated to conducting its work in a transparent manner to ensure that activities are always ethical, and that there is never a conflict of interest. Equally GXPZONE understands the importance of confidentiality and treat the information our clients share with complete discretion.
To provide high quality and time bound comprehensive solution from Product Development to grant of Marketing Authorisation and associated maintenance of licenses in a cost effective manner thereby enabling manufacturers or marketing authorisation holders to expand their business in global outreach.
GXPZONE understands the importance of confidentiality and treat the information our clients share with complete discretion. GXPZONE’S confidentiality agreements are in place to protect clients as well as other stakeholders including the general public. The highest ethical and confidentiality standards are maintained at all times.
GXPZONE places its customers at the centre of all activities and tailors its services to meet their needs. The team at GXPZONE work hard to provide a high level of customer service to our clients. By listening to the needs of our customers, we can ensure that we meet their requirements efficiently and cost effectively.
GXPZONE continuously works to improve the service we provide to our clients. We encourage our customers to provide feedback on their experiences working with GXPZONE. Our GXPZONE and Consultancy services case studies describe some of the projects we have undertaken and the ways in which we met our customers’ requirements.
GXPZONE has worked with a number of companies in the UK and around the world on various projects ranging from technology transfer to gap analysis and training. GXPZONE’S global activities can be viewed to learn more about our global reach. We are continuously exploring new markets and welcome enquiries from organisations in new and emerging markets.
Most of GXPZONE’S projects are coordinated at the head office in India, while the international offices support local activities in numerous countries depending on the requirements of the venture. GXPZONE’S consultants are based in various parts of world including Europe, Asia and North America and this provides the local knowledge needed to carry out overseas projects effectively.
OUR ASSOCIATES
CLOSED LOOP QUALITY LTD.
64 Brixham Road, Reading
Berkshire, RG2 7RB
UNITED KINGDOM
AZ PHARMA SERVICES LIMITED
Ground Floor, Unit B Lostock Office Park,
Lynstock Way, Lostock, Bolton, BL6 4SG,
UNITED KINGDOM
Dr. Subhash Pande
About 29 years of experience in Pharmaceutical Industry.
R&D, Manufacturing Quality Assurance and Quality Control functions of sterile, Oral Solids, dosage forms, Sterile API, Animal health care products Lyophilized Injections, DPIs, MDIs, Nasal sprays, Bio similar, vaccine and Pre-Filled Syringe products.
Execution of green field and expansion Projects with lean concept.
For last 15 years worked in Senior management – strategic and leadership role, ensuring organizational goals objectives, and business opportunities, through problem solving approach, within cGMP compliance framework.
Now associated with GXPZONE Pharma Solutions as a Technical Director and Principal advisor
Audit successfully faced:
USFDA Inspections – Oral Solids, Sterile and Non Sterile APIs , Semi Solids (Ointment and Creams )
MHRA / Eu GMP – Dry Powder Injectable, Oral Solids, Semi Solids
ANVISA – Dry Powder Injectable, Oral Solids; Inhaler’s; Biologics Semi Solids
INVIMA – Oral Solids; Biologics
WHO GMP – Oral Solid, semi Solids , Injections , Lyophilization process.
Sanjay Sharma
A dynamic professional with around 31 years of rich experience in Quality Control and Quality assurance Department. I am presently associated with M/S GXPZONE Pharma Solutions Pvt. Ltd. as a founder and Lead GMP Auditor. A project planner with expertise in planning, executing and spearheading Pharmaceutical projects and ensuring on time deliverables with GXP compliances. Excellent communication & interpersonal skills with strong analytical, team building, problem solving and organizational abilities.
I have successfully handled more than 60 inspections by reputed customer and Regulatory agencies like USFDA, MHRA, TGA, MCC, WHO, ANVISA, UKRAINE and regulatory inspections of AFRICAN countries successfully. I have a rich experience in conducting Global GMP, GDP audits and across other GXPs including ‘For Cause Audits’ for various clients.
He has conducted more than 100 API, EXCEPIENTS, Primary Packaging material, Warehousing and Formulations facilities across the Globe.
- Vision
-
To provide high quality and time bound comprehensive solution from Product Development to grant of Marketing Authorisation and associated maintenance of licenses in a cost effective manner thereby enabling manufacturers or marketing authorisation holders to expand their business in global outreach.
- Our Values
-
GXPZONE understands the importance of confidentiality and treat the information our clients share with complete discretion. GXPZONE’S confidentiality agreements are in place to protect clients as well as other stakeholders including the general public. The highest ethical and confidentiality standards are maintained at all times.
- Our Expertise
-
GXPZONE places its customers at the centre of all activities and tailors its services to meet their needs. The team at GXPZONE work hard to provide a high level of customer service to our clients. By listening to the needs of our customers, we can ensure that we meet their requirements efficiently and cost effectively.
GXPZONE continuously works to improve the service we provide to our clients. We encourage our customers to provide feedback on their experiences working with GXPZONE. Our GXPZONE and Consultancy services case studies describe some of the projects we have undertaken and the ways in which we met our customers’ requirements.
- Our Global Reach
-
GXPZONE has worked with a number of companies in the UK and around the world on various projects ranging from technology transfer to gap analysis and training. GXPZONE’S global activities can be viewed to learn more about our global reach. We are continuously exploring new markets and welcome enquiries from organisations in new and emerging markets.
Most of GXPZONE’S projects are coordinated at the head office in India, while the international offices support local activities in numerous countries depending on the requirements of the venture. GXPZONE’S consultants are based in various parts of world including Europe, Asia and North America and this provides the local knowledge needed to carry out overseas projects effectively.
- Our Associates
-
OUR ASSOCIATES
CLOSED LOOP QUALITY LTD.
64 Brixham Road, Reading
Berkshire, RG2 7RB
UNITED KINGDOM
AZ PHARMA SERVICES LIMITED
Ground Floor, Unit B Lostock Office Park,
Lynstock Way, Lostock, Bolton, BL6 4SG,
UNITED KINGDOM
- Mentor Profile
-
Dr. Subhash Pande
About 29 years of experience in Pharmaceutical Industry.
R&D, Manufacturing Quality Assurance and Quality Control functions of sterile, Oral Solids, dosage forms, Sterile API, Animal health care products Lyophilized Injections, DPIs, MDIs, Nasal sprays, Bio similar, vaccine and Pre-Filled Syringe products.
Execution of green field and expansion Projects with lean concept.
For last 15 years worked in Senior management – strategic and leadership role, ensuring organizational goals objectives, and business opportunities, through problem solving approach, within cGMP compliance framework.
Now associated with GXPZONE Pharma Solutions as a Technical Director and Principal advisor
Audit successfully faced:
USFDA Inspections – Oral Solids, Sterile and Non Sterile APIs , Semi Solids (Ointment and Creams )
MHRA / Eu GMP – Dry Powder Injectable, Oral Solids, Semi Solids
ANVISA – Dry Powder Injectable, Oral Solids; Inhaler’s; Biologics Semi Solids
INVIMA – Oral Solids; Biologics
WHO GMP – Oral Solid, semi Solids , Injections , Lyophilization process.
- Founder Profile
-
Sanjay Sharma
A dynamic professional with around 31 years of rich experience in Quality Control and Quality assurance Department. I am presently associated with M/S GXPZONE Pharma Solutions Pvt. Ltd. as a founder and Lead GMP Auditor. A project planner with expertise in planning, executing and spearheading Pharmaceutical projects and ensuring on time deliverables with GXP compliances. Excellent communication & interpersonal skills with strong analytical, team building, problem solving and organizational abilities.
I have successfully handled more than 60 inspections by reputed customer and Regulatory agencies like USFDA, MHRA, TGA, MCC, WHO, ANVISA, UKRAINE and regulatory inspections of AFRICAN countries successfully. I have a rich experience in conducting Global GMP, GDP audits and across other GXPs including ‘For Cause Audits’ for various clients.
He has conducted more than 100 API, EXCEPIENTS, Primary Packaging material, Warehousing and Formulations facilities across the Globe.
- Our Team Profile
-
Our Approach
Remain abreast with Global Regulatory changes and Challenges.
Adopt best Industry Practices for Drug development process.
To provide time bound and reliable scientific services.
Accelerate product approval using Pharmaceutical knowledge and expertise.
Remain competitive to the highly dynamic global market.