API Provider Services

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We have provided advice, training and quality systems development to aid clients that are interested in producing materials intended for use as APIs.   

Several of our clients were producing materials intended for use as excipients or food additives. They enlisted our services to expand their market base by assessing their deficiencies to ICH Q7 and FDA regulations and providing a project plan to remediate their current processes and procedures to meet FDA requirements. 

Project plans were implemented and effectiveness of the new process and procedures were assessed.

Certified Auditors are available for all types of auditing needs.  Projects have included:

• providing internal auditing services for quality departments as ISO requires an auditor cannot audit functions which they perform
• gap analysis of various clients to facilitate improvements to processes and overall compliance
• supplier audits for varied members of the medical device and pharmaceutical and bio-tech supply chain
• gap analysis for clients wishing to expand their current product lines into FDA regulated markets
• due diligence audits performed prior to merger and acquisition
• audits in preparation of PAI

We specialize in working with start-up companies moving products from R&D into pre-clinical GLP studies and through early and pivotal clinical studies through to commercialization.

Our expertise covers the technology transfer through process validation as well as method development, transfer and validation. 

We have provided advice, training and quality systems development to aid clients that are interested in producing components in medical devices.   

Several of our clients were producing materials intended for use in the automotive industry. They enlisted our services to expand their market base by assessing their deficiencies to ISO 13485  and FDA regulations and providing a project plan to remediate their current processes and procedures to meet FDA requirements. 

Project plans were implemented and effectiveness of the new process and procedures were assessed.

Implementation of a quality system compliant to ISO and FDA regulations.

With several years experience working in a constent decree environment, remediation support is a speciality.

We can review findings assessed by third party auditors, customer auditors or agency inspectors, and aid in the root cause analysis and CAPA development plan.

After developing the CAPA plan, we can assist in the implementation and access the effectiveness.

The FDA has focussed on  assessment and continued monitoring of suppliers.  We have designed supplier quality programs that include the initial selection of appropriate vendors, 

Supplier Quality Agreements are an essential part of your Supplier Quality Program.  We can assist you in drafting quality agreements for the varied types of suppliers in you supply chain.

Initial selection of suppliers and on-going assessment of suppliers is an essential part of FDA regulated industries.  We can help you develop procedures in selection of suppliers, qualification of suppliers and monitoring of suppliers throughout their lifecycle with your company.

A critical part of the Supplier Quality Program is auditing of suppliers.  Our auditors have experience in all aspects of the supply chain and their varied auditing standards.

• API 
• Excipients 
• Container Closure Systems 
• Packaging and Labeling
• Contract Manufacturing Organizations
• Contract Testing Facilities (GLP and GMP)
• Medical Device Component Manufacturers
• Calibration Service Providers
• Child Safety Packaging Testing Facilities
• Cosmetic Suppliers
• Distribution Warehouses including Cold Chain Warehouses

Services are available to help suppliers remediate any findings made during audits.

Training for auditors covers key topics such as:

• audit preparation
• audit conduct
• key items to look for during an audit
• audit reporting
• review of root cause analysis and CAPA
• CAPA effectiveness verification

Training in the ICH Q7 standard is available as well as differences in ICH Q7 and IPEC/ANSI standards for excipients.

Basic training in GLP regulations is offer and is tailored to your specific needs.

Training is tailored to your specific needs.  Training can be developed in:

• basic introduction to GMPs
• based on complaints received or internal audit findings
• based on recent FDA warning letters
• based on new FDA guidance documents