Our bioanalytical facility is around 12,000 sq. ft.
- Qualified, trained & experienced team of bioanalytical professionals
- Method development/validation for proprietary (NCE) and non-proprietary assays
- Bioanalysis of drug and metabolites in a variety of biological matrices
- Ability to develop and validate highly sensitive assays in low pg/ml range
- Ability to accommodate projects with rapid turn-around times
This full service covers study design, protocol & Informed consent form(ICF) development, CRF design, Ethics committee review, Selection of subjects, bioassay of drug / metabolite, Pharmacokinetic and statistical data evaluations, reporting of study results, and archiving of all study related data.
Sitec has 112 bedded state of the art Clinical facility. Each unit has adequate recreation facilities to conduct bio studies in healthy human volunteers, including women and post-menopausal women. We can conduct both male and female volunteer study simultaneously.
The BE & BA studies are carried out as per the appropriate SOPs. Our in-house quality and regulatory team ensure compliance to the protocol and ICH GCP guidelines.
SITEC LABS provides expert analytical services in all areas of testing from raw materials, excipients, APIs, Bulk drugs, intermediates to finished products. Data Integrity is being handled in compliant with (21 CFR Part 11) regulations subsections (a) to (k).
- Extractactable and Leachable Studies.
- Elemental Impurities studies by using ICPMS.
- Drug substance Assay and RS Method Development and Validation
- Drug Product Assay and RS Method Development and Validation
- Unknown Impurity Identification by LCMSMS and GCMSMS
- Genotoxic impurities quantification by LCMSMS and GCMSMS.
- Nitrosamines content quantification by LCMS and GCMS.
- Physicochemical characterization studies.
- Quality control and release testing.
- Deformulation studies (reverse engineering studies).
- In-Vitro equivalence Studies by using HPLC & IC.
- Polymorph studies by using TGA/DSC and PXRD.
List of Equipment:
- HPLC LC-2030C Plus (Shimadzu iseries)
- ICPMS(Perkin Elmer-Nexion 2000
- LCMS/MS Shimadzu-8060
- GC-MS/MS – Agilent (7010B GC/TQ, 8890 GC)
- Ion Chromatography – Thermo (ICS-5000)
- TGA/DSC – Mettler Toledo (TGA.DSC 3+)
CLINICAL PHARMACOLOGY STUDY EXPERIENCE:
- Bioavailability and Bioequivalence Studies
- Food Effect Studies
- PK/PD Studies
- 505 (B)(2) Studies
We have strong team handling BA/BE Studies in Healthy Volunteers with different dosage forms. We have conducted clinical studies on various dosage forms, which include:
- Solid oral formulations [Tablets (Immediate release & modified release e.g. ER, DR, SR), capsules, soft gels, etc.]
- Parenteral formulations
- Topical transdermal products
- Chewing Gums
- Nasal sprays
- Rectal Products (Suppository)
- Vaginal products
Our dedicated Volunteer data base management team maintains a Strong database of healthy volunteer pool.
- Strong Data base of more than 20,000 healthy volunteers
- Our pools includes all kinds of populations including females, post-menopausal women, Geriatrics.