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VCG1

Validation + Compliance

“Is what we do”

 

Celebrating 30+ years in the Life Sciences industry.

Headquartered in the San Francisco bay area with a satellite office in Shanghai, China & Santiago, Chile. VCG1, represents Validation & Compliance in multiple countries.

Our firm specializes in Quality Management Systems, from Audits to Process Validation. Whether you’re in need for Consent Decree assistance, Quality System Implementation, cGMP Audit / Remediation, or Facility Qualifications or Expansion, we will not only assist you in your short/long term objectives, but we’ll also provide the seamless integration that your company expect from a consulting firm.

We bring extensive experience and professionalism to every case and customize our support to your individual needs and concerns.

Our staff have been consulting for over two decades and started during the early 90s. We’re on the pulse with the current Pharmaceuticals (21 CFR Part 210 & Part 211) and Medical Device industry (ISO 13485, 21 CFR Part 820) Regulatory standards, and have monitored their evolution to inform our own approaches—all to give you exceptional advice that will conform to your company’s need.

Get in touch with us to set up a consultation or use the contact form at the bottom of this page to enquire whether our services are right for you.

 

Contact

➤ LOCATION

Patterson, CA
95363

☎ CONTACT

jmiranda@vcg1.com

(908) 875 5262

 

Areas of Practice


validation

Validation Quality Policy, User Requirement Specification (URS), Functional Specification (FS), Validation Master Plan (VMP), Installation (IQ), Operational (OQ), Performance (PQ) Qualifications, Test Methods (TMV) and Computer Software Validation (CSV)


Project Management

Organization, Problem Solving, Communication, Awareness, and Negotiation. Proficient in MS Project, Visio, and Solid Modeling Computer-Aided Design


Audits

Consent Decree, 483 Remediation, cGMP Audits, Third-Party Audits
 


BUSINESS STRATEGY

The startup and small business marketplace is still a new and fierce frontier that requires advice from Quality & Compliance Consultants who are deeply entrenched in the regulation particularities within the Life Sciences. VCG1 gives you a holistic approach so your company can get the best competitive advantage.


Quality

Quality Systems Implementation, CAPA, Non-Conformance (Identification, Initiation, Investigation, Disposition, and Closures)


Facilities

Commissioning, Facility Product Relocation, Facility Expansions, Facility Qualifications

 
 

 
 
All improvement happens project by project and in no other way.
— Joseph M. Juran
 
 

 
 
 

Let's Chat.

Use the form below to contact us regarding your Quality / Compliance inquiry. Please be as detailed as possible. Include your industry along with any specific compliance requests. To help us best service your inquiry, we recommend that you first describe the issue you’re having before telling us what you want to achieve. You may also email or call us to make an appointment.