About
Spectrum Pharmasol provides consultancy in pharma regulatory affairs and provides strategic services in any and every phase or aspect of the pharmaceutical product development cycle. We are based in Gujarat state which is a major contributor to the pharmaceutical sector of India.
Since various bodies and governments are involved in the process, we maintain high ethical standards and a strict environment of integrity in every operation and engagement. Our core and focused service spectrum comprise Regulatory Affairs service, API resourcing – Impurities, Analytical services, Turnkey projects and Contract manufacturing.
We understand that our clients are faced with matters of urgency, financial impacts, ethical and moral responsibilities along with the production challenges and finally government approvals and processes. All this multiplies when the product needs to touch many countries on different continents. We not only undertake various clinical studies under regulatory guidelines but also manage all pharmaceutical regulatory undertakings across various governments for our clients and make sure their product or therapy reaches the needy ones in time.
Our major expertise is in providing Bioequivalence Studies, Biosimilar Studies. Clinical Trial Management Consultancy, DMF, Dossiers, Medical Writing services, Regulatory services, Site Management Services, Statistical solutions, and specialized SAS Programming.
We have more than 12 years of experience in the area of Clinical Trial Project Management, Site Management, and Statistical & Medical Writing services. These include phase II to IV trials and BA/BE studies. We are offering comprehensive services in the field of Clinical trials. We have a team of GCP-trained, experienced professionals who are highly process-driven in performing global clinical trials. We have already been involved in more than 12 global phase II and III studies with 7 active sites as site management services. We are having experience in the area of Oncology, Gastroenterology, Nephrology, Neurology, Diabetology, Orthopedic, Cardiology, etc.
Client satisfaction is the hallmark of our success. We believe in quality, hard work, loyalty, and integrity. We always strive to be in the good books of our Clients.
Mission
Our Mission is to provide the best time-bound services to pharmaceutical companies worldwide in terms of quality, reliability, integrity, and value so that the end-users receive benefits in time. We will work closely and positively with governments, scientists, pharmacists, local health systems and who-so-ever involved in the process in order to bring results which benefit, protect, conserve and inspire life.
Vision
Our vision is to establish Spectrum Pharmasol as a global brand in various countries. We envisage ourselves to be the preferred and trusted clinical development partner for global pharmaceutical research and development and regulatory affairs.