Company Profile

V&C Valence, Inc. is located in Fort Lauderdale, FL, United States and operate in the Consulting Services Industry space.

V&C Valence, Inc. serve a diverse base of trustworthy clients around the globe, from emerging-to-enterprise organizations across virtually any specialty of the life sciences.

V&C Valence, Inc. has been engaged by recognized Consultant Firms and Global companies for Global assignments that supports both the industry and governments space providing tailored services to unanticipated situations and managing regulatory enforcement actions, which include prevention, remediation and certification in multiple areas including regulatory, manufacturing, and quality operations. 

 

V&C Valence, Inc. is a multidisciplinary blend team of highly experienced consultants and industry experts has offered an integrate strategic, innovated and tactical compliance, regulatory, and science & technology services to diversified projects involving scientific principles, technical aspects and regulatory requirements.

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V&C Valence, Inc. Team knowledge and experience assisted clients in:

  • Evaluating written procedures and standard operating procedures

  • Helping to interpret regulations in alignment with industry standards

  • Creating a program to meet current FDA expectations for GMP Compliance

  • Performing trend analysis

  • Providing corporate oversight programs and enhancement—including good governance practices; corporate quality/compliance functions and oversight practices

  • Implementing site oversight programs, including internal audits and performance metrics

  • Reviewing and enhancing management controls

  • Reviewing and enhancing organizational structures—including functions, reporting relationships, responsibilities, staffing and competence; communication systems and performance (vertical and horizontal); and independence, staffing, and competence of quality units

  • Analyzing, developing, and/or enhancing engineering requirements, specifications, and drawings, including HVAC, water, sterilization, and dust-control systems

  • Recommending effective flow of materials, equipment, and personnel

  • Assessing and enhancing facilities requirements manufacturing, assembly and packaging & labeling.

  • Addressing the facilities requirements of laboratory operations

  • Performing factory acceptance testing of equipment (FAT)

  • Qualifying facilities for sterile, low-bioburden, and non-sterile products

  • Qualifying facilities for intermediates, APIs, and finished drug products

  • Qualifying facilities for medical device components and finished products

  • Validating/qualifying computerized systems and electronic records; manufacturing, packaging, and labeling processes; cleaning, sanitation, and sterilization systems and processes; and facilities, critical utilities, and equipment

  • Validating analytical methods

  • Qualifying analytical equipment

  • Customize Training Program for Pharmaceutical Environment including aseptic areas  

  • GMP Training GMP for manufacturing and laboratory personnel

  • FDA Pre-Approval Inspections

  • Preparing for an Inspection and Interacting with the Investigator

  • Integrity of Records and Data

FY2020, V&C Valence, Inc. have offered services in the following areas:

  • Quality Systems Implementation and Remediation

  • Policy, Standard, SOP writing

  • Investigation writing and review 

  • CAPA plan reviews

  • Investigation reviews and writing

  • Batch record reviews for product disposition

  • Data Integrity Reviews – Lab and Manufacturing

  • Training

  • FDA Meeting Preparation

  • 483 and Warning Letter Responses

  • Statistical Method Review