Jeiven Pharmaceutical Consulting

Comprehensive consulting services for pharmaceutical and biotech manufacturers covering regulatory strategy, quality assurance support, customized training, internal audits, and clinical supply management.

A specialized training course designed to ensure control over pharmaceutical processes in compliance with FDA regulations, focusing on data integrity, GMP document review, and proper documentation practices.

A customized training program focused on preparing pharmaceutical, biotech, and medical device organizations for a successful FDA inspection, highlighting key GMP and Data Integrity guidelines.

Customizable training program covering cGMP, FSMA, and regulatory compliance for manufacturers, packagers, labelers, and holders of dietary supplements.

Auditing services for Interactive Response Technology (IRT) and Electronic Data Capture (eDC) vendors to ensure compliance with 21 CFR Part 11, Annex 11, and other regulations.

Comprehensive QA/QC consulting services to help pharmaceutical, biotech, medical device, and dietary supplement companies comply with global regulatory requirements and FDA Good Manufacturing Practice (GMP) standards.

Custom training programs delivered on-site covering a wide range of GMP, GCP, GLP, and Clinical Supply topics.

Global GMP audit services including pre-engagement qualification, routine surveillance audits of CMOs, internal facility mock audits, and Pre-Approval Inspection (PAI) preparation to ensure compliance with FDA and health authority quality standards.

Customizable Good Manufacturing Practices (GMP) training course tailored to company needs, including recent examples of FDA Warning Letters and 483s.

Internal company audits including evaluation of documentation, security, shipping, handling, storage, and receipt for firms handling controlled drug substances.

A training program targeting personnel responsible for the development, review and approval, document control, and training of a company's SOPs to ensure compliance with regulations.

Comprehensive Quality and Regulatory strategy consulting to medical device, drug/device combination product, and in vitro diagnostic device companies, including auditing, training, and support for regulatory submissions and clinical trials.

Customizable training programs covering international ethical and scientific quality standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials.

A customizable training course designed to provide proper understanding of and compliance with GLPs (21 CFR Part 58) for analytical and bioanalytical laboratories or animal testing facilities.

Customized regulatory affairs training programs to help teams learn about the drug approval process, FDA and EMA regulations, and differences between CDER and CBER.

Training program presenting the essentials of device GMPs and Quality System Regulations (QSR, 21 CFR 820), designed to promote employee compliance to FDA regulations.

Comprehensive auditing services to ensure that dietary supplement products and ingredients are manufactured and distributed in compliance with 21 CFR Part 111, 21 CFR Part 117, and FSMA regulations.

Good Laboratory Practice compliance audits for non-clinical laboratory facilities conducting safety and toxicology testing.

Good Clinical Practice audits required for companies conducting clinical trials on investigational medicinal products or medical devices involving human subjects.

Audits ensuring that quality management systems comply with Quality System Regulations (QSR) for medical device stakeholders.

An automated, comprehensive drug reporting system which monitors the flow of DEA controlled substances from their point of manufacture through commercial distribution channels to point of sale or distribution at the dispensing/retail level.

Good Distribution Practice audits ensuring that medicinal products are distributed under controlled conditions.

Assessment of the investment potential of healthcare companies and contract research organizations of all sizes.