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Author Archive

Preparation, Review and Approval

January 27, 2010  |   Featured   |   admin  |   Comments Off

Preparation, Review and Approval

Preparation, review and approval for product registration and licensing documentation and applications including: FDA Premarket Notifications (510(k), FDA Premarket Approval Applications (PMA), Canada Device Licensing, MDD-CE Technical Files, exemption substantiation documentation.

Expertise and Preparation

January 27, 2010  |   Featured   |   admin  |   Comments Off

Expertise and Preparation

Expertise and preparation of required compliance documentation including Design History Files (DHF), Device Master Records (DMR), Risk Management Evaluation, Corrective Action and Preventative Action systems (CAPA), Medical Device Reporting system (MDR), Post Market Surveillance Strategies.

Microbiological Testing

January 27, 2010  |   Featured   |   admin  |   Comments Off

Microbiological Testing

Microbiological testing services including bioburden, sterility, disinfection efficacy, particulate analysis microbial limits, BI certification, cytotoxicity, and sterilant resistance.

Compliance and Quality Assurance

January 27, 2010  |   Featured   |   admin  |   Comments Off

Compliance and Quality Assurance

Compliance and Quality assurance that provides confidence with both internal and external customers.

Comprehensive Compliance Auditing

January 27, 2010  |   Featured   |   admin  |   Comments Off

Comprehensive Compliance Auditing

Comprehensive compliance auditing services using FDA QSR, ISO 13485, Canada MDR. Follow up and sustaining programs.

Comprehensive Laboratory Testing

January 27, 2010  |   Featured   |   admin  |   Comments Off

Comprehensive Laboratory Testing

Compliance Systems International along with it's strategic partners can provide comprehensive laboratory testing and analysis services.

LexaMed

January 26, 2010  |   Affiliates   |   admin  |   Comments Off

LexaMed

LexaMed is a company dedicated to providing the pharmaceutical, medical device and biotechnology industries with quality, compliant,  state-of-the-art  services in the areas of consulting, auditing, and laboratory testing.  Our team of industry professionals has over two centuries of pharmaceutical and medical device experience.  The skill-sets of our consultants are complementary and allow us to address situations of any subject or scope with technically compliant, practice comprehensive solutions.  Our consultants are experienced in Quality Systems, Validation – product, process and equipment, Aseptic operations, Sterilization – radiation, ethylene oxide, VHP, steam, liquid, Regulatory Compliance, Microbiology, Engineering and Analytical Methods. Our laboratories are ISO certified and have been in operation for more than 25 years, initially as BEC Laboratories, now as LexaMed, providing quality services in microbiology and chemistry.  These labs have been expanded to include many other offerings including D and z-value determinations, BIER unit exposures, package integrity and container closure challenges, stability and accelerated aging under ICH specified conditions.  Dedicated laboratory space and personnel are available for custom R&D protocols. Lexamed.net