Welcome

•November 21, 2009 • Comments Off

After years of experience in pharmaceutical industry, Mr. Nitin R. Parab had started Swami Samarth Pharmatech which provides the complete Pharma and Medical Device solutions in the documentation part required for Regulatory Affairs and Quality Assurance with the joint ventures of European experts.

Also expertise in launching the products in Brazil right from the registration of products with the ANVISA, We do help the Registrations in Tanzania, Romania.

SSP works in Strategic Partnership with M/s. Interactive Consulting Associates, GmbH, Switzerland.

ICA do offer consulting services all around the world in USFDA, EU and other countries audit preparation. Our audit reports are accepted by Mexican authorities and also by Japan Health authorities. Our experts had worked in European pharmaceutical industry for at least 20 years. They collectively have more than 500 years of experience. All of them have held Senior Management positions.

ICA group has direct contacts to the FDA, EMEA, CEFIC and further associations, along with the WHO, Switzerland. We are in joint activities for audits and documentation with M/s. Interactive Consulting Associates, GmbH, Switzerland. The company owned by Dr Paul Scherer (Managing Director). Other activities and services are listed in our Services page.

SSP works in Strategic Partnership with M/s. CEpartner4U, Netherland

CEpartner4U services include on-site and cyber consulting for all products under the medical device directive (MDD), in-vitro diagnostic device directive (IVDD) and active implantable device directive (AIMDD).

CEpartner4U is your independent Authorized Representative, confidentially maintaining your technical file and registering your Class I and IVD products with the Competent Authorities in all EU memberstates.

CEpartner4U is staffed with a team of experienced Lead Assessors and medical equipment researchers. Their experience includes:

  • Project engineering for a major Dutch medical research organization.
  • Managing a multitude of medical consulting projects and training programs include
  • Medical product development, market research, development of quality test programs for medical devices, ISO 13485, GMP, hospital quality standards and CE-marking of medical devices
  • ISO 13485 and sterilization processes assessment and several years of medical device directive (MDD) audits in Europe, Israel and the USA as certified lead assessor for a Notified Body
 
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