www.qc2.com in Albuquerque, NM, US (United States)

www.qc2.com/qc2_005.htm

Company Overview:

Quality and Compliance Consulting, Inc. (qcc) provides GCP and GLP compliance audits, systems and facilities qualifications and audits, Standard Operating Procedure (SOP) review and preparation services, and training to the pharmaceutical and biotechnology industries.

Company Statistics:

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Contact Details

Address:11100 Country Club Drive Ne, , Albuquerque, NM, 87111, United States

Telephone:505 323 6438

Fax:

Web:http://www.qc2.com/qc2_005.htm

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Pages on www.qc2.com's website :

qc2

Quality and Compliance Consulting, Inc. (qc²) provides worldwide audit and consulting services to the pharmaceutical, medical device, and biotechnology industries.

List of Services

qc² provides the following services: GCP, GLP, and BioAnalytical Audits • Investigative Sites (In-Study or Pre-FDA Inspection) • Phase I Units and PK/PD Studies • Institutional Review Boards • Clinical Trial Files - Essential Documents • Clinical Trial Data Listings • Clinical Trial Reports, ISSs,

Sponsor, CRO, and Vendor

• Audit of data management, biostatistics, and information technology systems for the entry, management, and reporting of clinical investigation data • Audit of Computer System Validation (CSV).

SOPs

Gap analysis of existing SOPs Preparation and rewriting of SOPs to ensure compliance to GCPs, applicable regulations, and ICH guidelines Review of laboratory SOPs to ensure they meet industry standards, Good Laboratory Practice (GLP) regulations, and BioAnalytical Validation Guidelines Standard

GCP and GLP Audits

• Audit of investigative site operations to determine adequacy of documentation and procedures, and to ensure your trial will be carried out in a controlled manner, per protocol, and in compliance with regulations • Audit of ongoing and completed studies (Phases I-IV) at investigative sites to

Web Pages

Web Pages:

qc2

Web | Quality and Compliance Consulting, Inc. (qc²) provides worldwide audit and consulting services to the pharmaceutical, medical device, and biotechnology industries.

www.qc2.com/

Sponsor, CRO, and Vendor

Web | • Audit of data management, biostatistics, and information technology systems for the entry, management, and reporting of clinical investigation data • Audit of Computer System Validation (CSV).

www.qc2.com/qc2_005.htm

SOPs

Web | Gap analysis of existing SOPs Preparation and rewriting of SOPs to ensure compliance to GCPs, applicable regulations, and ICH guidelines Review of laboratory SOPs to ensure they meet industry standards, Good Laboratory Practice (GLP) regulations, and BioAnalytical Validation Guidelines Standard

www.qc2.com/qc2_004.htm

Consullting

Web | • Audit Plan Development • Audit Follow-Up and Review of Corrective Actions • Preparation for FDA Inspections • Mock FDA Audits Consulting List of Services GCP, GLP and BioAnalytical Audits Sponsor, CRO, and Vendor Audits Standard Operating Procedures Training and Customized Workshops Links Contact

www.qc2.com/qc2_003.htm

Web | Please contact us for more information. Quality and Compliance Consulting, Inc.

www.qc2.com/qc2_010.htm