Welcome to Our Company!

Mtech Consulting Group (Mtech) provides a wide variety of services to help pharmaceutical companies meet International Regulatory challenges. Our team members specialize in guiding pharmaceutical companies to establish efficient, cost-effective and quality systems, which will pass inspection and produce high-quality products.

About

us

01

About Mtech
Mtech Consulting Group provides a wide variety of services to help pharmaceutical companies meet International Regulatory challenges. Our team members specialize in guiding pharmaceutical companies to establish efficient, cost-effective and quality systems, which will pass inspection a...

02

Mission
Mtech strives to be the best provider of Compliance solutions. We will deliver maximum value to our clients and partners. We hire, develop, and retain talented individuals who want to be part of a great place to work, where contributions to superior results are recognized and rewarded.

03

Our Characteristic
FDA regulatory consulting requires very specialized knowledge in each Industry Sector (pharmaceuticals, medical devices, biotechnology, foods, animal drugs etc.). We have put together the most experienced and respected members in their respective fields. Each of our consultants has ...

Our

Value

We define value creation as a process that consists of three elements; leadership, relationship, and creativity. Leadership is providing our clients good direction.  Relationship is earning the trust and confidence of our clients over time by delivering measurable results. We understand the present and future needs of our clients carefully, working together in a meaningful way to eliminate possible areas of concern or danger and capturing opportunities for improvement and learning by leveraging both our strengths and yours.  Creativity is the third element of how we intend to create value in our relationship which consists of providing new capabilities to enable both learning and increased productivity.

Our 18 years of business experience focused solely on the pharmaceutical sector allowed us to develop significant domain knowledge as well as to establish our global infrastructure.  Our business maturity, fueled by organic growth enabled us to build systems and unique processes that address both the front (client, sales) and back stage (delivery, accounting/finance, HR) operations.

We have successfully completed projects with small, mid to large-size pharmaceutical companies and have an established back stage support system in place to properly execute projects of varying size and degree of complexity. Time and again we have risen to prove our ability to mobilize resources both efficiently and effectively for clients in start up phase (Advancis Pharmaceuticals) to those with global operations (Pfizer, formerly Wyeth).

Our dedicated team of professionals will deliver results meeting the stated project objectives both on time and exceeding your quality expectations. We constantly strive to learn, grow, and progress.  To this extent we foster continuous education and active participation of our staff in professional affiliations such as ISA, ISPE, and PDA. Our team comprises of degreed engineers, validation specialists with a minimum of bachelors degree in Lifesciences or related field of study, and qualified Project Managers who are PMI certified with at least five to seven years of direct pharma experience.

Our partners are subject matter experts in large scale compliance initiatives and from their experience developed the Compliance View® Real Time Project Management application. This web based tool offers a comprehensive solution that integrates all the compliance program management functions from initiation to completion combined with powerful collaboration, knowledge and document management capabilities.

Our

Services

Compliance Consulting

With over 18 years of experience in Compliance Consulting and serving over 30 clients, Mtech is a leading provider of the US FDA Regulatory Compliance services in the United States and abroad. Our goal is to help our clients set up a solid foundation while minimizing potential risk through approval or compliance proces. The underlying principle articulated in the cGMP regulations, of developing systems under which pharmaceutical products are manufactured, resulting in drugs that exhibit consistent high quality attributes.

Program Management

Compliance View® is a proprietary solution provided by Mtech which enables our clients to effectively manage projects, collaborate between people, track & forecast resources. This end to end project lifecycle management solution dramatically improves the validation business process, bring visibility into the process and surfaces the data.Using Compliance View, Mtech has experience in delivering the following major components of Program Management.

Global Integration & Deployment

When pharmaceutical companies have operations globally, regulatory pressures on the firm and its application development activities increase dramatically. The need to enforce corporate policies and internal development policies while meeting production demands and beyond becomes a top priority. Mtech has implemented processes and tools to streamline application development and delivery, while complying with industry and government regulations. Mtech has expertise in providing support for global deployment of the following solutions.

IT Implementation & Services

IT Implementation and Integration Services provides expert services in designing, building and delivering business-driven technology solutions. We help our clients gain competitive advantage by using Internet-based technologies to make their businesses more responsive to market opportunities and threats, strengthen relationships with customers, suppliers and partners, improve productivity and reduce information technology costs.

Greetings

Thank you for taking time to visit our website. Mtech has always tried to excel and become your regulatory partner that you can rely on.

We thank you for your trust in us. As you may already know, Mtech has been ranked as one of the top by the global search portals sites like Yahoo (www.yahoo.com) and Google (www.google.com) in the area of US FDA compliance consulting. We have an industry high 90% retention rate of our clients. Our clients have always come back to us regarding any Compliance needs and have been our biggest source of new business as well.

Based on these professional experiences, Mtech is seeking to form a meaningful long-term business relationship with you. Our practice of double-checking your technical information enables us to provide prompt and efficient services for your unique US FDA issues in a very organized manner. In addition, our staff can provide the service in various languages such as English, Spanish, German, Hindi and Tamil.

The

Skills

67
Warning Letter Resolution
44
Computer system Validation
83
Equipment Qualification
18
SOP Development

knowledgebase

CGMP Defined

cGMP are the Current Good Manufacturing Practices followed by the pharmaceutical and biotech firms to ensure that the products produced meet specific requirements for identity, strength, quality, efficacy and purity. FDA regulates these industries to ensure cGMPs are being followed by using the following tools...

Contacts

Mtech Consulting Group
216 Stelton Road Suite A1
Piscataway  Nj 08854
Telephone: +1-732-926-1700
Fax:  +1-732-909-2001