Regulatory Affairs

FLEXIBLE SOLUTIONS FOR YOUR HIRING AND RECRUITMENT NEEDS

Scrumworkx'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 Scrumworkx 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.

OUR GLOBAL REGULATORY SERVICES INCLUDE:

• 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