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Dr. Hans-Joachim Kramer: Over 35 years of experience in Sourcing Products/ Regulatory Assistance/ CROs/ Generics/ APIs; Quality Management (GMP,GLP, GCP, GCLP, ISO 17025, etc.); Laboratory & Vivarium Planning, Set-up and Management of Laboratories & Animal Units, Animal Studies & Alternatives, Risk Management, Qualification/ Validation; Regulatory and Research Toxicology, Hygiene/ Disinfectants, Microbiology, Medical Devices (Biocompatibility), and more...

HJK
UK

Dr. Usha Karunakaran: Twenty years of experience in innovative New Drug Discovery, R&D programs, expertise in screening of NCE’s and Natural Products in Herbal (Health, Skin care and Cosmetic applications) based programs - in vitro and in vivo. Therapeutic areas include Inflammation, Asthma, COPD, Diabetes, Obesity, Antibacterials, Malaria, Dermatological applications and others. Specialties: New Drug Discovery, pharmacological based in vitro assays and in vivo efficacy and toxicity in various disease models. Natural products screening, and more...

Dr. Kamaldeep Singh Grover: Around 20 years of experience working with CROs & Pharmaceutical Companies. Rich experience in Quality Systems (GLP, GCP, GCLP, ISO 9001, ISO 15189, ISO 17025). Owner of Questa Life Sciences, providing high quality consultancy & training to GLP & GCP regulated companies, independent QA Audits for Preclinical & Clinical Studies (Phase I through to Phase III). Clinical QA audits including all aspects of the clinical development process. Training courses public and in-house on GLP, GCP, ISO 17025, ISO 15189, Computerized System Validation, and more...

KGrover
KS Rao

Dr. K. S. Rao: Over 40 years of global experience in safety evaluation development. Board Certified Toxicologist with the leading US Pharmaceutical, Agrochemical & Food industries & CROs. Offers expert advice for product development strategies, reviews, protocols & reports, toxicology summaries and dossiers for regulatory submission, monitors studies, & provides solutions to testing programs in Drugs/Biotech, Biosimilars, API impurity qualifications, & Pesticides. Emeritus Member of the Society of Toxicology in US. Led multidisciplinary teams in designing/constructing, maintaining, managing, of preclinical research/ toxicology & animal facilities in USA & India. Mentored/ trained several toxicologists. Published & presented papers in international journals/seminars. Principal author of more than 200 study reports, submitted to various authorities (FDA & EPA, EU, Japan & India), and more...

Dr. Henk A. Tennekes: Over 40 years of experience in Toxicology and Pharmacology, including custom design of R&D programmes, CRO selection, study design and protocol review of in vivo & in vitro studies (ADME, Toxicology, & secondary Pharmacology), monitoring & follow-up of non-clinical studies, pharmacokinetic (PK) and toxicology data analysis and reporting, preparation of expert reports, PK and toxicology summaries, contributions to Investigator’s Drug Brochures (IDB), Investigational New Drugs (IND), New Drug Applications (NDA), Dossiers According to Directive 91/414/EEC, Biocidal Product Directive 98/8/EC, etc., preparation of manuscripts for scientific journals (ghostwriting), and in-sourcing and staff training courses (upon consultation), and more...

HTennekes 

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