Our extensive experience, specialized skills, and personal contacts enable us to move your product application through the approval process at the various regulatory agencies.

 

Regulatory services

We have represented clients at the FDA, EMEA, and HPFB including pre-IND,
post-Phase II, pre-NDA, and scientific advice meetings. Our services include:

Preparation and filing of drug, biologic, and device submissions, including IND/CTA
Electronic submissions
Electronic-submission plans
Data management
Document conversion
	Building the eNDA & eCTD
Presentations at FDA, EMEA, and HPFB Advisory Committee meetings
	Representation at FDA, MHRA, EMEA, and HPFB meetings, including pre-IND, post-Phase II, and pre-NDA, and scientific advice meetings
Reporting and tracking of adverse events
Preparation and maintenance of regulatory forms and files
Regulatory consultation and liaison with global regulatory services
Statistical consultation
Preparation of annual reports
US and Canadian regulatory agent liaison

 

Regulatory audits

Preparation of study sites for FDA audits
Conduct of clinical trial, data, regulatory, and protocol compliance audits
Design of clinical audit procedures in accordance with FDA Compliance Guide
Data audits based on sound statistical design
	Database QA via audits against CRFs and verification of calculated fields (99% confidence of greater than 99% accuracy)
Audits conducted on pass/fail basis and on statistically relevant sample sizes

 

Regulatory experience

Numerous completed and approved NDAs, BLAs, ANDAs, NDS (using the CTD format), and ANDS, including electronic submissions, NDA sections, integrated summaries, clinical pharmacology sections, and study reports in accordance with ICH guidelines.

 

Review areas:

Dermatology	Renal
Anti-infectives	Cardiovascular
Ophthalmic	Endocrine and metabolism
Biologics	Antiviral
Radiopharmaceutical	Veterinary
Anticancer	Pilot drug and drug advertising
CNS	OGDs