Technical And Strategic Consulting To The Pharmaceutical Industry
Farmastrateegia Ltd.
Registration No. 12149078

Helping clients optimize pharmaceutical development and gain regulatory approval.


Our Work Product

INDs

Investigational New Drug Applications

NDAs

New Drug Applications

ANDAs

Abbreviated New Drug Applications

BLAs

Biologic License Applications

IDEs

Investigational Device Exemptions

[510(k)]s

Premarket Notifications

PMAs

Premarket Approvals

Marketing Applications

Investigator Brochures and Summary Reports

and more...

In the clinical arena, we regularly develop protocols, case report forms, clinical study reports, and regulatory submissions to multiple FDA reviewing divisions. We also undertake related tasks such as identification of investigators and contract laboratories, review and management of statistical analysis, preparation for and representation at FDA and advisory committee meetings, as well as implementation of data safety monitoring boards.
We provide ancillary support services including implementation and management of adverse event reporting systems; literature searching and database management; and production of regulatory submissions in both paper and electronic form, including the assembly, proofreading, delivery, and maintenance of regulatory files.
As companies grow, we assist in the development of in-house capabilities in all our areas of expertise through tailored in-house training

Contact Us

  • Address: Aadamiansu Pärispea küla, Kuusalu vald, Harjumaa 74706, Estonia
  • Phone: (+372) 507-0151
  • Email: KKook@farmastrat.net