OUR TEAM

Mr. Suresh Khanna

Engineer by education, Designated Partner, Dossier Solutions & Services LLP.

Was founder Chairman of M/s.Stabicon Life Sciences Pvt. Ltd. a Contract Research & Development Organization. He is a Business Advisor and Member of theBoards of a few companies in both India and abroad. He has contributed, as Executive Director, towards establishing KEMWELL, oneof the largest Contract Manufacturing Company in Bangalore. Has wide experience in areas of API's, Formulations, Diagnostics,Analytical equipment and Surgical. Also, was a Member of the Board of Millipore Pvt. Ltd. India, a JV company of Millipore CorporationUSA. Suresh has been a Past President of Karnataka Drugs & Pharmaceuticals Manufacturer's Association (KDPMA) and IPA,Karnataka State Branch. HQ member of IPCA and currently the Hon. Secretary of the Indian Pharmaceutical Association (IPA). He isalso a Steering Committee Member of KDPMA, Chairman of Pharma Training Institute and Permanent Trustee of KarnatakaPharmaceutical Trust (KPT), a not for profit Organization, engaged to uplift Pharmacy Education in India.

Regulatory Affairs

Dr. A. Rajani

Pharma Regulatory professional , Post Graduate in Chemistry , Post Graduation Diploma in Pharmaceutical management from IPER Pune 25+ Years experience in QA, Regulatory Affairs, QC, ASD & TTD Department. Adept in compiling Dossiers in CTD Format for Regulated markets, handling of eCTD software and responding to Regulatory queries. Worked with major Indian and overseas Pharma Companies like MERCK, Strides, BPRL, Star Drugs , and currently Dossier Solutions & Services LLP. Expertise in Regulatory matters, leading administrative, operational, business promotion and development projects

Ms. Vanishree

M.Pharm with 14+Years of experience in Regulatory affairs and quality Assurance (Formulation) in Pharmaceutical industry. Compilation of CMC part of EU-CTD and other abbreviated dossiers for International Markets. Well-versed working with XML, the backbone of CTD. Managing regulatory submission and approval process, also assuring complete and timely response to the Regulatory Agencies during application review. Coordinating during all the regulatory audits and customer visits and supporting for compliance activities. Worked with major Indian and international Pharma Companies like All India Tablet industry, Micro Labs Ltd, Oman Pharmaceutical products Co LLC, Oman and currently Dossier Solutions & Services LLP.

Ms. Renu Koul

Post graduate in Pharmacy with over 20 years extensive experience in the area of visualising and designing of promotional materials for healthcare industries. Development of packaging materials. Worked in Ranbaxy.

Quality Management Services (QMS)

Mr. Goutam S Saha

Veteran in Pharmaceutical, Biologics and Medical devices Quality domains. Bangalore based consultant. Topper in M. Sc. (Organic Chemistry); PG Research as JRF on medicinal plants, UGC project; Certificate course in Clinical Trial Management from ICRI, Bombay. Started career in R&D and Quality. Sailed around India & Aboard over 27 years. Nurtured in Hoechst, Pfizer, Lupin, Ranbaxy, Universal, Sentiss, Strides, Agila, Cipla BT. Leaded audit management for USFDA, MHRA, TGA, MCC, WHO, PICs, ANVIZA, etc. Highly skilled, result oriented accomplished team leader in design, C&Q, reverse engineering of Greenfield projects for potent drugs involving Platform technology and ASTM 2500E risk based approach.

Expertise in QMS of NCE, Sterile, OSD, r-DNA, Bio-similar, Stem-cell, in facilitating Process validation, Cleaning validation, Operational excellence and Quality culture. Investigated 1000 of OOS, OOT, failure RC, and data integrity breach (ALCOA) and implemented CAPA and strategic remediation to import alert. Established GMP Trainer and Coach as per ICH, EudraLex, CFR and aseptic practices, behavioural GMP, ALCOA, computer system validation with proven track in India, Kenya and China. Supplier audit : Anthem Bioscience, Eurofins Advinus, Gland Chemical, GVK, Sai Life Science, Vindhya Organics, Bajaj Life Science, Pharbaco JSC (Vietnam), MoH Myanmar, Hisun Pharma, Biomab Shanghai. Comprehensive assessment of productivity - GSK-CBPVL Rabies vaccine and Cipla corporate quality function on behalf of McKinsey INC. Strategic remediation for Torrent, Syngene (Biocon), Apotex, Hetero and Malladi as collaborative effort with QCG.

Facilitated USFDA, PIC/S, ANVIZA, INVIMA, GCC, EMEA audit and certification for Aurigene (DRL), Wockhardt, Wintac, Aizant, Unichem, Virchow, Evertogen.

Mr. Harish Babu M.L

M Pharm Pharmaceutics. High-energy, focused senior Corporate Quality/R&D professional with 21 years of overall experience in Global Quality, Process Development & Technology Transfer, Clinical research associate, Technical Services, Contract Manufacturing operations & R&D Project management in Pharmaceutical industry. Successfully completed Executive general management program from IIM Bangalore. Proficient in performing Global Quality Audits & Due diligence- completed about 220 audits. BA/BE study Monitoring : Monitored as CRA/Sponsor representative about 40 BA/BE studies – US & EU markets at different CRO locations. Having rich exposure: Quality Assurance & Product transfer/Scale up exposure – transferred from R&D to plant transfers & International exposure: worked as Project lead- transferred about 25 Sterile products from India to Strides Poland facility and established the technology transfer procedures in the new Sterile facility at Poland.

Active participation in successful regulatory audits by MHRA, TGA, MCC, ANVISA, WHO, USFDA & other customer audits and extensive support during USFDA audits in different units - handled different dosage forms such as Parenterals, Solid Orals, Pelletization technologies, Compaction processes, Dry powders, Liquids & Ointments.

Ms. Matilda George

M.Sc. in Organic Chemistry from Vikram University, Ujjain in 1985. Offering chronicled success of nearly 30 years in spearheading Quality Operations in Pharmaceutical industry (QC/QA). A strategist & implementer with track record of establishing Quality & reliable standards. Expertise in designing and setting up of Quality Control Laboratories (Chemical & Microbiology). Training, Qualification and building up of Quality Talent resources for Laboratory analysis. Extensive expertise in planning and organizing the Regulatory and client audits and dealing with Investigation management. Led the Site Quality control team for the Remediation project and related activities and further coordination with international quality experts. Worked on 21 CFR Part 11 & Data Integrity compliance in Quality Operations. Data compilation & Stability management.

Dr. Prakash Deshpande

PhD in Analytical chemistry with over 40 years of experience in Quality Control QA and Regulatory Dossier compilation. Worked in Public Testing laboratory and domestic Pharmaceutical companies ( Alkem)

Ms. Smitha Rao

Over 18 years' experience in Pharmaceutical Microbiology. Has worked as In-charge of Microbiology laboratory in MNC pharma company.

EHS & Engineering Management including Equipment And Process qualification / validation

Mr. B Karthik

30+ years of proven years of leading and executing EHS (Environment, Health, Safety) best practices in Manufacturing facilities, supply chain operations, office /Commercial environment and construction projects. Hands on knowledge on developing and implementing customized business systems on lines of ISO management systems (9,14,45,51K) across multiple global locations.

Carried out EHS programs (assessments/ audits / training / awareness session including electrical safety/fire safety), Process Safety Management (PSM) Training & implementation, Behavior Based Safety (BBS) implementation and IS 14489 plant assessments, in Chemical Manufacturing facilities (including API facilities), Pharma Formulations, Oil &Gas, Jewellery refining and Electroplating, amongst other industries.

During his corporate career, got trained on 1) OSHA, CFR 1926, Construction Safety / Contractor Safety Management norms for projects, at St. Louis, MO, USA. 2) Chemical Process Safety Management Expertise at Basle, Switzerland. 3) Behavior Safety training at Melbourne, Australia. Trained as ISO Auditor (@ Perry Johnson) for Integrated ISO systems implementation as well as for conducting corporate international EHS audits, at Morristown, NJ, USA. Masters in Environmental engineering by qualification as first batch pass out in India, (1985) as well as Safety professional by diploma offered by Govt. of Gujarat, (1990). Certified Lean expert through Green Belt training and project execution. Passed out MBA in HR to link people perspective to EHS.

Has professional experience with companies such as Monsanto (Bangalore), Sandoz (Ankleshwar), Astra Zeneca (Bangalore) and BASF (Mangalore)

Mr. Maneesh Merwade

Pharma 11 years of experience in equipment and process qualification/validation, troubleshooting to support operations, engineering upgrades, process scale-up and ramp-up. Held different positions in an engineering role at global pharma organizations such as Genentech (California), Boehringer Ingelheim (Ohio), Pfizer (New York)

Hands-on working experience with processing systems and utilities from processing skids, downstream processing equipment, aseptic filling, packaging & inspection and plant utilities–their engineering,installation, operation, commissioning and qualification. (over 25 projects Approx value 50 million USD)

Expertise in cleaning, sterilization and equipment qualification (IQ, OQ, PQ, CV etc.) as per 21 CFR Part 210, 211 for Pharmaceutical & Biopharma facilities..Maintainence of the validated state ensuring compliance for GMP environment.

Facility and Engineered Systems design, installation, commissioning, qualification and operation for Pharma & Biopharma to optimize throughput while meeting compliance requirements.

Provided expert guidance in cGMP, regulatory compliance, Consent decree remediation, Manufacturing process, equipment and facility
investigations, remediation of observations by regulatory authorities.

Mr. H.A.Nagabhushana

B.E.(mechanical) Bangalore University, Having 20 years of professional experience in pharmaceutical engineering, through projects and plant engineering out of which 10 years in sterile plants as Head -Engineering. Worked for GSK, Anglo French, Wintac Ltd and Aurobindo pharma, etc. Have faced multiple international audit, including USFDA audits