PV Solutions Private Limited is a knowledge process outsourcing company based in Chandigarh India and was registered here in 2015. The company has been providing a range of services to some of the top pharmaceutical companies worldwide in the area of Pharmacovigilance (PV) and Regulatory Affairs, and has a vast experience and expertise in working in both domestic and international markets. Ours is an ISO 9001:2015 certified company, providing a whole range of PV consulting services to support you in PV operations and help you to identify gaps in your PV system. The newly introduced regulations of this industry often make it difficult for pharmaceutical companies to keep up with shifting regulatory landscape. With the help of PV Solutions as pharmacovigilance experts, we can offer assistance with; PBRER, DSUR and RMP writing; signal detection; pharmacoepidemiology; systems development and implementation; PV auditing; inspection support and implementation of new regulation and legislation changes. These services are provided through a team of our well-experienced employees and also in association with various independent consultants from US and Europe, including PV and Regulatory Strategists, ex-Regulators, Drug Safety Physicians and Scientists, and PV auditors.
- PV (e.g. writing PV documents, PV training and audits & inspections support);
- Regulatory Affairs [e.g. writing dossier for Marketing Authorisation Application (MAA)/New Drug Application (NDA) and generic applications];
- Publishing Services [includes compiling, reviewing, publishing and electronic submissions of dossiers to Regulatory Authorities in Electronic Common Technical Document (eCTD) format];
- Other Medical Writing Services.
Ms. Upasana Prabhakar
PV Consultant
Upasana Prabhakar has nearly two decades of working experience in the pharmaceutical industry in the United Kingdom. She started her career as a research scientist with a global pharmaceutical company in the UK, working in the area of oncology and inflammation. She then moved to a new role as a Medical Information Officer. Thereafter, she worked in drug safety and global PV Quality Assurance. She moved to a leading UK consultancy in 2009 and has now established herself as an independent consultant.
Morell David
PV Consultant
Morell has over 25 years PV and drug safety experience gained in the UK Regulatory Agency, MHRA (over 19 years) and working for various large, medium size and small biopharmaceutical companies. During his time at the MHRA Morell was a Senior Assessor (Reviewer) and Head of a Therapeutic Unit with responsibility for monitoring, evaluating and reviewing the safety of biopharmaceutical products used in Oncology, Haematology, Rheumatology, Gastroenterology and enzyme replacement therapy. He is based in the UK and he is a world-renown expert on the international medical terminology, MedDRA, gained as the Coordinator of the original ICH M1 Expert Working Group which was responsible for developing the MedDRA terminology, as the UK delegate on the MedDRA Management Board, EU delegate on the ICH MedDRA Points to Consider Working Group (M1P) and EU representative on the CIOMS Expert Working Group responsible for development of Standardised MedDRA Queries (SMQs).
Dr Seema Jaitly
PV Consultant
Dr Seema Jaitly is qualified in Medicine from Charing Cross and Westminster Medical School, UK in 1992 and has worked in hospital medicine for four years. She is based in the UK and has worked in the pharma industry for over 18 years at CROs and companies spanning clinical research, medical affairs, pharmacovigilance and the EU QPPV role.