US FDA Regulatory Submissions

Premarket Notification (510(k))

Investigational New Drug Application (IND)

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Biologic License Application (BLA)

Find out whom to look to for answers to your questions and queries in FDA system

Prepare answers to FDA questions

Prepare inquiries to FDA for answers to your specific questions

Foreign Drug Manufacturer Registration and Listing and Medical Device Registration, Listing

Writing of Medication Guides and Package Inserts

Scientific Literature search for your Regulatory affairs and scientific projects and followed by preparation of reports

Writing of standard operating procedures and scientific papers

If you do not have time and resources to devote to writing of SOPs and scientific papers we can take care of that for your company. We can help you write scientific papers per the requirements of different scientific journals.

Professional Development /Training courses are also available for US Regulatory Affairs

For example: 510 (k) / IND / BLA / ANDA / NDA / Quality System Regulations (QSR).

Providing Information for clinical investigators

Looking for extra hands for regulatory assistance for your company

Indian Regulatory Affairs

A team of highly qualified individuals who have proven track record in Indian regulatory processes will take care of all your company’s Indian regulatory affairs needs.