Investigational New Drugs:
Provides writing support for pre-IND FDA meetings , chemistry, manufacturing, and controls compliance, non-clinical study reports and summaries, clinical experience summaries, non-US clinical experience summaries, Investigator's Brochures, pharmacology, toxicology, and ADME.

Electronic Submissions:
Delivers experience in working with document management systems and save your company time and money as we take care of the preparation and filing of Investigational New Drug, Abbreviated New Drug, and New Drug Applications.

Common Technical Documents:
Contributes full support for all phases of CTD writing and publishing.

Standard Operating Procedures:
Gives expert assistance in successfully designing, preparing, and maintaining clinical and regulatory SOPs, including process engineering consulting.

Regulatory Mop-up:
Offers the support needed to complete clinical study files and "Mop-Up" clinical programs: data management, data analyses, preparation of clinical study reports and clinical study synopses …and more