Consulting in Medical Device

Regulatory:

Regulatory strategy (initial FDA contacts, pre-submissions, IDE submissions, device classification, appropriate regulatory submission)
Regulatory submissions: US FDA, EU, Canada, Asia/Pacific, , Rest of World (RoW)
Product labeling and packaging development and/or review
Coordinate product testing (biocompatibility, electrical safety/EMC, biocompatibility, sterilization validation)
Regulatory intelligence and guidance interpretation

Quality Systems/Compliance:

Quality System definition and implementation
Compliance audits and internal audits
Post-market Compliance communications: Responses to 483s and Warning Letters, Field Actions (recalls, market withdrawals, field corrections), MDR/Adverse Event reporting
Training: develop training materials, coordinate/deliver employee training sessions

Design Control:

Develop/review/audit Design History Files, Technical Files, Design Dossiers
Testing coordination: Electrical safety, materials characterization, biocompatibility, shipping/packaging

Clinical Studies:

Testing coordination: Electrical safety, materials characterization, biocompatibility, shipping/packaging
Clinical trial strategy, protocol development and/or review
IRB submissions
Clinical trial monitoring

Consulting in Pharma/Biotech

Interpretation of EU and USA and Japan/Korea/Canadian regulations and guidlines
Science-based strategies for addressing all technical aspects of drug development (labeling, chemistry/manufacturing, preclinical , clinical)
Planning of pharmaceutical, toxicology and clinical development programs
Identification and monitoring of suitable and reliable partners to carry out the required development work
Protocol development and project implementation
Clinical phase I-IV support
Paediatric Investigational Plans (PIPs)
Orphan Drug Designations
CTAs/INDs and eCTD/MAAs/NDAs/BLAs and global GCP/GLP/GMP audits
eCTD dossier prepatation and submission
Preparation EU or US or EU/US "Application for Designation as Orphan Medicinal Product"
Pre-submission meeting with the EMA and finalization of documents
Compilation and Submission of Orphan Drug Dossier to the EMA
Developing orphan drugs is always a challenge for different reasons, among which are precisely defining the condition through clinical symptoms & signs, physiology and biochemistry, and hence deciding on the eligibility of the patient for treatment.
Conducting studies of test drug against controls such as placebo may not be ethical, and against a comparatorproblematic, where there is an existing an unmet medical need and there is no "gold standard" of treatment.
The small numbers of patients raises questions over reaching justifiable conclusions on efficacy and safety.

Growth failure	Pre-submission meeting EMA, and Rapporteurs, Prepare Strategy, write,compile and submit MAA/CTD. Change designation during MAA procedure: Unprecedented pioneering orphan strategy, Clarification meetings Rapporteurs.
Severe, debilitating inflamation (Granulomatosis)	Presubmission meedting EMA, andRapporteurs, Prepare strategy, writge, compile and submit MAA/CTD
Oncology	PIP submission, Protocol Assistance, SME meetings