Samanthikasharma's News

Dossier | DMF Submission – ASEAN Regulatory
http://www.makrocare.com/in... — MakroCare specialize in regulatory consultancy and can act as representatives in various parts of the World. The regulatory affair services include eCTD preparation, dossier/DMF submission.
0 Comments     Bury     samanthikasharma     24 weeks ago

Japan Product Registration | Authorized Agent | DMF Submission
http://www.makrocare.com/in... — MakroCare Consulting with local presence (office in Tokyo) can act as Local Representative for  your company in Japan and also provide In-country Caretaker services for foreign DMF holders.
0 Comments     Bury     samanthikasharma     24 weeks ago

Regulatory Compliance Review - 21 CFR Part II Compliance
http://www.makrocare.com/in... — MakroCare Consulting help its clients achieve these goals through its Computer system validation services. The few of the validation services include 21CFR part 11 assessments and remediation planning, Qualification protocols.
0 Comments     Bury     samanthikasharma     24 weeks ago

Regulatory Compliance 21 CFR - Pharmacovigilance Audit(GPVP)
http://www.makrocare.com/in... — MakroCare Consulting is a one stop shop for regulatory compliance solution implementations, validations, audits and process definitions. The expert professionals of MakroCare have complete awareness about upcoming as well as current regulations like 21-CFR-part 11,210, 211 and GxP.
0 Comments     Bury     samanthikasharma     24 weeks ago

eCTD Submission – Dossier | DMF Preparation Services
http://www.makrocare.com/in... — MakroCare has powerful, feature-packed eCTD software for regulatory submissions, its document/knowledge management solution that virtually does everything from store to organize to share to manage your eCTD submissions quickly, efficiently, reliably and above all, securely.
0 Comments     Bury     samanthikasharma     24 weeks ago