Preferred Partner for
Clinical Research
Consultant for Clinical Research for global Pharmaceutical companies
Bioequivalance Studies
We advise for the successful conduct of BA/BE Studies/Clinical Trials.
Clinical Trials
We conduct Site Initiation and Qualification Visits and Monitoring Visits.
Medical Writing
We are providing Medical Writing services to complete the dossier. Expertise in writing CTD.
Pharmacovigilance Services
Fulfilling the Pharmacovigilance obligations of the MA holder. Literature Screening etc.
Vision
To become a preferred Partner/ Consultant for Clinical Research for global pharmaceutical companies
Mission
To assist the pharmaceutical companies for clinical research and development through cost effective monitoring/audit services
ENRICHED AND DIVERSE EXPERIENCE OF MORE
THAN TWO DECADES IN PHARMACEUTICAL
AND CRO INDUSTRY
THAN TWO DECADES IN PHARMACEUTICAL
AND CRO INDUSTRY
Your Partner in Clinical Research
- Services offered by best experts of Clinical Research and Medical Writing
About Us
Founder & Managing Director - Shireen Rao
We are a team of highly experienced professionals engaged in auditing/monitoring of bioequivalence studies and clinical trials for our clients. Most of our team has worked in the Pharma or CRO industry and have expertise in auditing/monitoring of clinical/bioanalytical aspects of bioequivalence studies.
Has over 20 yrs of diverse experience in pharmaceutical and CRO industry specializing in Bioequivalence Studies, Formulation and Analytical development, Documentation Procedures and Quality Systems. Has extensive in-depth technical, clinical/bioanalytical and regulatory experience and knowledge of PK and bioanalysis, was instrumental in setting-up a full- service CRO and have executed more than 1000 bioavailability and bioequivalence studies for all major regulatory region – USFDA, UK-MHRA, EMEA, ANVISA, TGA-AUSTRALIA, TPD-Canada, MCC-South Africa etc. Successfully faced numerous audits and inspections from US-FDA, ANVISA, affsaps-FRANCE, AGES-Austria, DCGI etc.