Bioavailability & Bioequivalence

Clinical Research:

The clinical team has over 60+ man years of experience in the field of clinical research with expertise in executing challenging clinical studies besides conventional dosage forms.

Naturotac has an excellent scientific expertise with capabilities of handling challenging studies to support various regulatory agencies like DCGI, FDA, EMEA and MHRA.

Naturotac Bio has a world class infrastructure to facilitate a quality conduct of research and is a GCP compliant facility manned by an experienced team of medical professionals and supported by a team of clinical investigators, physicians, Clinical Research Associates, pharmacists, paramedics and laboratory technicians.

A well equipped ICU with the entire necessary infrastructure to support 160 beds for all clinical pharmacology studies.

he main components of infrastructure at Naturotac are well equipped facilities, state-of-the-art equipment, regulatory compliant software and hardware and secured networks.

Expertise:

Various Dosage forms:

Inhalation/Pulmonary (MDI, DPI, Nasal Spray)
Injectable : IM, Subcutaneous, IV [Anesthetic drug BE study (e.g. Propofol)]
Transdermal (Patch, Gel, Cream)
Vaginal
Oral – Tablet/ Capsule ( IR, DR, MR, SR, CR, ODT) / Suspension / Granules (In Apple Sauce)
Sublingual

Various types of Studies:

Fasting and Fed
Single and multiple dose
Parallel, Crossover ,Partial and full replicate
Special Population
Drug-drug interaction (DDI)

Pharmacokinetic Interaction studies:

State-of-the-art facility:

Screening Area
Subject Housing Area with 160 beds (Separate housing for female subjects)
Blood Sample Collection & Processing Area
Dining / Recreation Area
6 Bedded ICU
Dedicated Deep Freezer and Sample Storage Area
Dedicated Pharmacy

Bioanalytical Research:

Our scientist are experienced and expertise in small molecule, metabolite, peptides, Hormones, steroids and other endogenous molecules.

Our highly qualified team of scientists with in-depth knowledge in instrumentation and application of LC-MS/MS technology enables timely method development. We validate our analytical methods as per global regulatory requirements / customer need.

Naturotac has labs that have all SOPs and systems to support the bionalytical studies for DCGI,FDA, MHRA and EMEA. The team has in-depth expertise in the recent regulations and inspections.

Our support includes the following:

Method development
Method Validation
Regulated sample analysis