Shertech’s manufacturing division is a full-service registered contract manufacturer of pharmaceutical products. We handle everything from clinical supply and commercial scale manufacturing to warehousing and distribution. We are also cGMP (current Good Manufacturing Practice) certified, so we can manufacture soap, gels, spray and medicine.
Laboratory Services and Laboratory Audits
- Utilizing the HPLC
- The GC
- Thin layer chromatography
- SOP compilation
- Stability studies
- Indoor Air Quality Testing
- Indoor Air Quality Management Programs
- Industrial Hygiene Sampling
- FDA Compliance Surveys
- Practice Mock Inspections
- Noise Testing
- Safety Inspections & Training
- Engineering Services
- Computer troubleshooting
- Software/Hardware configuration
Shertech offers PET imaging facility assistance services for either “fixed site” or “mobile” hospital installations to include the following:
- Clinical protocols development
- Imaging applications assistance
- Scheduling and patient flow improvement
- NOPR registration and training assistance
- Procedure coding and reimbursement assistance
- Referring physician marketing services
- Participation in customer clinical research protocols
- Cyclotron facility space for on site research (ultra short lived isotopes)
PET products and support are available 365 days per r national reimbursement support specific to PET products and procedures are available through Reimbursement Revenue Solutions.
Regulatory Submissions and Facility Audits
There are three IND types:
- An Investigator IND is submitted by a physician who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. A physician might submit a research IND to propose studying an unapproved drug, or an approved product for a new indication or in a new patient population.
- Emergency Use IND2 allows the FDA to authorize use of an experimental drug in an emergency situation that does not allow time for submission of an IND in accordance with 21CFR, Sec. 312.233 or Sec. 312.34.4 It is also used for patients who do not meet the criteria of an existing study protocol, or if an approved study protocol does not exist.
- Treatment IND5 is submitted for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place.
There are two IND categories:
- Research (non-commercial)
The IND application must contain information in three broad areas:
- Animal Pharmacology and Toxicology Studies – Preclinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans, (Included are any previous experiences with the drug in humans (often foreign use))
- Manufacturing Information – Information pertaining to the composition, manufacturer, stability, and controls used for manufacturing the drug substance and the drug product. This information is assessed to ensure that the company can adequately produce and supply consistent batches of the drug.
- Clinical Protocols and Investigator Information – Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks — Also, information on the qualifications of clinical investigators–professionals (generally physicians) who oversee the administration of the experimental compound–to assess whether they are qualified to fulfill their clinical trial duties — commitments to obtain informed consent from the research subjects, to obtain review of the study by an institutional review board (IRB), and to adhere to the investigational new drug regulations
Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.
Permit/License Review and submissions
- Nuclear Permit and license
- Pharmaceutical Permit and license
- Business Permit