Bioavailability & Bioequivalence

Clinical Research:

  • The clinical team has over 100+ man years of experience in the field of clinical research with expertise in executing challenging clinical studies besides conventional dosage forms.
  • Synergen Bio has an excellent scientific expertise with capabilities of handling challenging studies to support various regulatory agencies like DCGI, USFDA, EMA and MHRA.
  • Synergen 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.
  • Well-equipped ICU’s with necessary infrastructure to support 160 beds for all clinical studies.
  • At Synergen Bio, our infrastructure is built to global standards, featuring well-equipped facilities, advanced state-of-the-art equipment, regulatory-compliant software and hardware systems, and secure networks that ensure data integrity and confidentiality throughout every stage of research.

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 and rectal suppositories
  • 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)

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 scientists 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.

Synergen Bio has labs that have all SOPs and systems to support the bioanalytical 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