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Health Care & Pharmaceutical Services

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VPCI, Inc.
Business Development and Management Services
- Strategic planning
- Licensing-in and licensing-out activities
- Project definition and prospecting
- Due diligence support services (legal, financial,scientific, regulatory)
- Negotiation, agreement and transactional support
- Integration and culture management
- U.S. satellite office coordination, planning and oversight

Manufacturing and Technology Support Services
- User requirements, conceptual and final design evaluation
- Laboratory, process and analytical development methods
- Critical utilities, cross-contamination and cleaning systems evaluation
- Technology transfer program management
- Personnel training and organizational development
- Process automation and analytical technology evaluation
- Documentation system and validation program evaluation

Regulatory Compliance Services
- Preparation of registration files (CMC, NDA, ANDA, DMF)
- Pre-approval inspection and FDA audit
- 483 and Warning Letter resolution management
- Foreign establishment U.S. Agent compliance
- Clinical and scientific program management
- Interpretation of regulations and GMP guidelines and trends

VPCI offers every one of its clients:
- A highly experienced team of international experts who assure technical expertise and regulatory compliance in a wide variety of areas
- A proven history of successfully turning around complex pharmaceutical operations
- A strong base of experience interacting with health regulatory agencies worldwide
- A carefully coordinated group of business professionals to guide you through business development activities
- A long list of satisfied customers who have benefited from our conscientiousness, attention to detail, and consistent communication throughout and beyond a project’s life cycle.

Contact Information

Address

Telephone

Craig Kruman – CFO
CKruman@VPCInt.com

5640 W. Maple Road, #312
W. Bloomfield, MI 48322

(248) 538-5150

                                                       http://www.vpcint.com

 

Registrar Corp
Registrar Corp assists companies in the Drug, Medical Device, Food and Beverage, and Cosmetics industries with U.S. Food and Drug Administration regulatory compliance. The firm is headquartered in Hampton, Virginia, and has assisted over 20,000 companies in more than 150 countries. Registrar Corp operates 18 regional offices in Europe, Latin America, Asia, and the Middle East.

Contact Information

Address

Telephone

David Lennarz - Vice President
dlennarz@registrarcorp.com
      

144 Research Drive                  
Hampton, VA 23666

(757) 224-0177

                                                       http://www.registrarcorp.com