Pharma Consultation Services

R Cowan Consulting Services LLC
3107 Crest Lake Court
Arlington, TX 76016
United States
ph: 817-247-2945
rogercowan@pharmaconsultation.com

Services

Services Overview

We specialize in the areas of contract GMP drug / device manufacturing, quality assurance, and labeling/distribution of outsourced clinical supplies and other development batches. Aseptic manufacture of sterile drug and device products is an area of expertise.

We connect the client to a CMO (Contract Manufacturing Organization) appropriate for the product under development and then provide ongoing project management and the necessary technical expertise to the relationship.

Services Offered:
The client can contract R Cowan Consulting Services LLC to perform one or any combination of the following services.

Contract Manufacturing Organization Determination and Assessment
From a large supplier database, the consultant will recommend appropriate CMO(s) for manufacture and development of client product. This will be followed up with a Confidentiality Agreement, a comprehensive Technical Assessment and a Supplier Quality Audit of the potential CMO manufacturing facility.
Manufacturing Protocol and Cost Quotation Review
The consultant will support the client in the review and negotiation of the contractor manufacturing protocol and quotation from a technical standpoint.
Technical and Quality Agreements
The consultant will support the client in the review and negotiation of these two agreements detailing the client- contractor responsibilities from a quality and technical standpoint.
Technology Transfer Generation
The consultant will facilitate and, if required, prepare the Technology Transfer document between client and contractor detailing the formula, specifications, and manufacturing procedure for the developmental product.
Manufacturing/Validation Protocol Review
The consultant will review all contractor manufacturing or validation protocols and technical reports for quality, GMP and adherence to current validation principles and regulations.
Batch Manufacturing Record Review
The consultant will fully review and, if necessary, revise the contractor's draft batch record against the details of the Manufacturing Protocol and Technology Transfer. This is performed prior to the batch record pre-approval by the client. After successful manufacture, the completed batch record and testing results are fully reviewed by the consultant from a quality viewpoint prior to post-approval by the client.
Contract Batch Observation
As the client's representative, the consultant will observe the manufacture of the development and/or clinical batch at the CMO location, checking for adherence to the batch record requirements and GMP principles.

Cleanroom Contamination Control and Microbiological Investigation / Solution

Will perform a thorough review of the cleanroom environmental history and procedures. A full assessment of media simulations, utilities, aseptic personnel practices, sterilization equipment, disinfection practices and cleanroom design will be completed. Based on this data, a detailed investigation report will be provided with recommendations as to an action plan for remediation.

Quality GMP Drug / Device
Manufacturer Audit

The consultant can perform a comprehensive GMP Audit/Inspection of a finished drug/device manufacturer. This audit may be for the purposes of qualifying a CMO supplier, a mock GMP inspection of the client's own manufacturing facility, or in preparation for a FDA Pre-NDA Approval Inspection. The client will receive a detailed audit report with any observations referenced against the applicable regulation.

Quality GMP Supplier / Vendor
Compliance Audit

The consultant can perform a comprehensive GMP Audit/Inspection of an API, Excipient or Packaging supplier. This audit may be for the purposes of evaluating a potential new supplier or as a re-qualification of existing suppliers. The client will receive a detailed audit report with any observations referenced against the applicable regulation.

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R Cowan Consulting Services LLC
3107 Crest Lake Court
Arlington, TX 76016
United States
ph: 817-247-2945
rogercowan@pharmaconsultation.com

Pharma Consultation Services

Services

Contract Manufacturing Organization Determination and Assessment

Manufacturing Protocol and Cost Quotation Review

Technical and Quality Agreements

Technology Transfer Generation

Manufacturing/Validation Protocol Review

Batch Manufacturing Record Review

Contract Batch Observation