SERVICES

Support SERVICES

Formulation, analytical development & stability services

We can support your analytical and product development needs through our associate  company Stabicon  Life Sciences Pvt. Ltd., Bengaluru, India,  which is approved by Various International Regulatory Authorities and number of MNC’s. Stabicon is engaged in Product development / Analytical method Development / Validation  and Stability services:

  • Product development: Total development of product from lab scale to pilot plant scale to actual production scale. This service includes both for Medicinal Drug product   formulation and Medicinal Drug Substances API.
  • Product Performance testing (including dissolution, release rate and content uniformity)
  • Release testing for Active Pharmaceutical Ingredients (APIs and formulated drug products.
  • Analytical Method development and validation
  • Microbiological method development and validation
  • Routine analyses of products - HPLC/GC etc.
  • Total Product characterization
  • Impurity profiling
  • Stability studies
(All the data supported by necessary Chromatograms and Spectrums).
Patent Services

We provide the following Patent related services ;

  • Prior art search
  • Patent specification drafting and filing
  • Prosecution of Patent application 
  • Technology insight or technology landscape reports
  • Freedom to operate searches
  • Patent portfolio auditing
  • Registration and protection of designs in India and in other jurisdictions.
  • The searches are carried out using both proprietary and freely available databases covering patent and non-patent literature. The patent specifications are drafted according to the need at the national and international levels.
Bio-availability and Bio-equivalence studies

We monitor and co-ordinate Bioavailability / Bioequivalence / Clinical Trial Studies / Pre-clinical trial studies through well established study centres or your preferred partners in India for various dosage forms

Pharmacovigilance
  • Adverse event reporting based on literature search.
  • SmPC, Pack insert, DSUR and PSUR writing / updation

Types of Services

» Regulatory Services

» Support Services