Regulatory Affairs

FLEXIBLE SOLUTIONS FOR YOUR HIRING AND RECRUITMENT NEEDS

TekFormix's regulatory affairs specialists works to help a company or organization meet all state, local, federal, international, and industrial regulations that apply to their products Regulatory bodies have become stricter than before and are constantly evolving guidelines and regulations to reduce risk to the patient and enhance product quality. At TekFormix Life Sciences, we understand the nuances of complex regulatory requirements and offer regulatory support to Pharma and Biotech companies at every stage of their clinical development. Our Regulatory Affairs (RA) department in co-operation with our international network of regulatory affairs professionals, facilitate regulatory solutions for drug or device at every stage.

We provide regulatory advice, solutions and support for every regulatory requirement.

EUROPEAN UNION AND GLOBAL ACQUISITIONS

Case Report Forms (CRFs)
Product information (SPC, PILs)
Drug Substance Services: DMF, IND, Manufacturing, Import & Exports
Drug Product Services: NDA, ANDA
Pre-IND and Pre-NDA meeting with FDA
Writing and compilation of INDs, NDAs, ANDAs, 505(b) (2) and supplements
eCTD submission
Providing the clearances
Regulatory support for clinical trials, Facility Inspections
CMC (Chemistry, Manufacturing, Control) and Pre-Clinical toxicology
Regulatory agency interaction
Pricing and Market Authorization Approval