V. Chandra Sekhar – PresidentHas a rich experience of more than 20 years in pharmaceutical and CRO industry, Currently the President of Perfomics Analytical Labs LLP, He has worked in several leading Organizations in the industry including Dr. Reddy’s, Aurobindo Pharma, GVK BIO and VIMTA LABS,.
He has a vision of developing Perfomics as a fully functional speciality end to end Analytical and Bioanalytical service provider; an excellent strategist and a prudent decision maker with insightful and articulate vision. He has been an exemplary leader in establishing and maintaining long term business relationships.
He has a diversified experience and knowledge of various functional domains in the CRO industry including Clinical Operations, BA/BE studies, Pre-clinical and Discovery Bio analysis. His Leadership had contributed immensely in the growth of companies both in “Technical “ and “Business “fronts which he was associated with.
Heading global regulatory inspections that are successfully carried out like USFDA, WHO, ANVISA, UK MHRA, EMA & DCGI.
A. Rajasekhara Reddy – Vice PresidentHas an experience of more than 15 years in Pharmaceutical Industry. Currently the Vice President of PERFOMICS Analytical Labs LLP has the scientific excellence which drives Pharma Business to growth in relation to Analytical and Bio Analytical research. Has tremendous knowledge on the product development, which further opens avenue towards drug design, developing novel analytical methods by Qbd and their validations.
He has vast Experience in developing and validating the analytical methods as per the regulatory requirements. Prior to Perfomics he had been associated with Orchid Healthcare and Dr. Reddy’s. He was the domain leader of Analytical and Bio Analytical Research at Orchid Health Care for more than 12 years.
Heading global regulatory inspections that are successfully carried out like USFDA, WHO, ANVISA, UK MHRA & EMA.
Mr. Goutham - Head Bio-Analytical DeptHaving 10 years of experience in area of regulatory compliance domains for Clinical Research, pharmacokinetics, bioanalysis, quality assurance, site monitoring and vendor qualification in GCP/GLP environment, expertise in method deveoplment and validation for different regulatory submission ,especially in MHRA,FDA,MCC,ANVISA,WHO,EMEA,.
Almost 90 method development and completed atleast 350 clinical-studies.Development and validation of generic and NCE molecules for bioanalysis in biological matrix e.g. Plasma, blood, serum, Urine, tissuesetc.
Successfully faced USFDA, WHO, ANVISA, MHRA, EMA & DCGI regulatory audits.
Mr. Rama Krishna - Head Quality AssuranceAn individual with a vast experience in Quality Assurance.
Has rich exp of about 4.5 years in Analytical and Bio-analytical QA field with overall more than 10 years of experience in Pharmaceutical industry. Expert in developing standard operating procedures and updating them to meet international and national regulatory requirements.
Have hands on experience in facing and handling regulatory audits like USFDA, MHRA, WHO and Global/national sponsor audits. Creative & Learning attitude, excellent soft skills, Hardworking, goal oriented and Self-Motivation are his strengths. He Was associated with Orchid Pharmaceticals Chennai since its inception in 2005 and had contributed immensely in the growth of Orchid both in “Technical “ and “Regulatory”fronts.
Mr. Hemanka Rao - Head Analytical Dept.Has an experience of more than 07 years in Pharmaceutical Industry. Currently the Head – Analytical Dept @ PERFOMICS Analytical Labs LLP
Preformulation & Development support (Drug substance and Excipients)
Very good at Trouble shooting and providing Regulatory support (analytical queries)
Setting up and operating Stability Department (as per ICH)
Good Documentation Skills (SOPs, Protocols, Specifications)
Expertise in Facility Set-up w.r to Lab, commissioning and maintenance
Create, review and revise the standard operating procedures (SOP) required for the department
He has vast Experience in developing and validating the analytical methods as per the regulatory requirements. Prior to Perfomics he had been associated with Dr. Reddy’s & Orchid Healthcare.
Heading global regulatory inspections that are successfully carried out like USFDA,UK MHRA & EMA.