Pharmaceuticals and Biotech
HTC members have extensive experience in preparing and submiting regulatory documents for drugs and biotech projects including cell therapy products (small molecule, proteins, sterile liquids, topicals, oral, ophthalmic products) .
Nothing is ever 100% in the submissions area but not knowing where you are going is a sure way to stall any project. HTC can provide you with Regulatory Strategy and Planning for your submission needs.
We have supported the preparation of:
IND, NDA, sNDA,NDS, 505(b)(2), ANDA, ANDS, MTA, CTD and eCTD and hybrid submissions.
We can provide personnel to prepare submissions on-site in your Offices or we can prepare your submissions and provide you with electronic and/or paper copies.
HTC can provide complete electronic publishing of your submissions including your labeling with well control production costs.