Arvind is an established pharmaceutical scientist having more than 22 years of experience in the field of Analytical Research. He has done his M.Sc. in Analytical Chemistry. He was associated with R&D centre of reputed pharmaceutical companies like Lupin and Torrent. He is expert in method development & validation\Verification of many challenging pharmaceutical dosages forms like emulsions, Semisolids (cream, ointment, gel, etc), Ophthalmics (emulsion, suspensions etc), Solid & liquid orals (Tablets, Capsules, pellets, soft gelatine capsules, DR, ER, MR, suspensions, Solution) etc, Inhalations (DPI, MDI, inhalation solution and suspensions) Derma, Oncology products.

He has vast experience in all functions of analytical department like method development, validation/verification, DIssolution development, tech transfer, stability, regulatory query, compliance and quality assurance. Arvind has good analytical knowledge w.r.t. all regulatory requirements of regulated pharma markets like US, Europe, Brazil, ROW etc and India market as well. He has extensively worked for ANDA and DMF. His leadership in previous organizations has played a significant role in the success of challenging pharmaceuticals product development.

Besides above, Arvind was heading Pharmaceutical Equivalence Center (ERFAR) in the past organisation which was the first approved centre by ANVISA outside Brazil. In his leadership, the Pharmaceutical Equivalence center has sucessfully performed studies for more than 15 products, submitted them to the Brazilian market and got approval. He is expert in execution of Method validation/Verification as per RDC 166, RDC 53 with justification of Acceptance criteria. He is also expert in evaluation of Linearity as per RDC 166 and special expertise in the justification for the failure of Linearity in various models as per ANVISA requirements.

Dr.Atul is an established pharmaceutical scientist having 23 years of experience in the field of Analytical Research. He has done his M.Sc. (ICA), PhD in Analytical Chemistry. He was associated with R&D centre of many renowned & worldwide reputed pharmaceutical companies like Lupin, Glenmark, Wockhardt and Torrent. He is expert in Solid state characterization (XRD, FTIR, Raman, NIR etc.) Impurity isolation and its characterization (1H,13C 2DNMR). He is proficient in end to end product development of complex formulations & drug substances support with respect to analytical aspect like Method Development, Method Validation and Method Transfer and support to successfully ANDA and DMF submission. He has contribution in many more ANDA and DMF approvals and successful launch in US, EU, Brazil market in past companies for complex and non-complex Solid & liquid orals (Tablets, Capsules, pellets, soft gelatine capsules, IR, ER, MR, suspensions, etc.), Semisolids (cream, ointment, gel, etc.) Inhalations (DPI, MDI, inhalation solution and suspensions) Derma, Oncology products. He has good leadership skills to manage the big size of the team. He has good command in project management and regulatory compliance to handle the agencies query to get the approval. Besides this he has a strong command in quality compliance and cGMP aspects as he has faced multiple audits by regulatory agencies.

He has a vast experience in method development and method validation of nitrosamine impurities by LCMS/MS,GCMS/MS in drug substances and drug products for sartans and non sartans molecules. He is expert in all functions of analytical department like method development, validation, Method Transfer followed by QC testing and support to successfully ANDA and DMF submission. Dr.Atul have various paper publications in his account. Dr.Atul has good analytical knowledge w.r.t. all regulatory requirements of regulated pharma market like US, Europe, India ,ROW, etc. His leadership in previous organizations has played significant role in the success of challenging pharmaceuticals product development.