FROM REGULATORY SCIENCE TO CLINICAL AFFAIRS AND TRAINING… SOLUTIONS BEGIN HERE.
WE’LL MEET YOU WHERE YOU’RE AT.
Whether you are a startup firm bringing your first product to market with minimal experience, or an established medical device company looking for the best strategies and fastest paths to launch a new product, or a multinational firm that needs additional resources, we have the solutions you’re looking for.
REGULATORY SCIENCE
Create new and update existing regulatory strategies, develop initial regulatory compliance plans and maintenance strategies, submissions planning and preparation of IDEs, IND, 510(k), De Novo, PMAs, 513(g)s, breakthrough submissions, CE dossiers, CEPs, license application, combination products in CTD format, submission project management, serve as liaison with WW regulatory bodies, and US Agent, regulatory due diligence, overall regulatory compliance activities.
REGULATORY OPERATIONS
Manage and organize regulatory submission information, design standard and custom submission formats, build and assemble submissions, QA check, e-copy creation, FDA eSubmitter software check and shipment to regulatory bodies.
QUALITY SYSTEMS
Develop strategies and establish GMP, QSR, GCP systems , design and write GXP procedures and records, perform QS gap analyses, conduct GCP, GMP, QSR, MDSAP internal and global supplier audits, (onsite and remote), support during FDA inspections, ISO certification and compliance audits.
CLINICAL AFFAIRS
Develop clinical study design, manage pilot clinical studies, site management, develop protocol and CRFs, prepare monitoring plans, manage and facilitate DSMB.
TRAINING
Executive (C-level) and employee general and customized QS/GXP training, including combination product quality processes, FDA interaction meeting and inspection preparation and practice.
SPECIFICALLY, CANOPY REGULATORY HAS EXPERIENCE
IN THE FOLLOWING AREAS:
REGULATORY AFFAIRS
- Regulatory submissions; IND, IDE, PMA, 510(k), BLA, CTD
- MDD/R Design Dossier & Technical Files Management
- Worldwide Registration Planning and Dossier Preparation
- Regulatory Compliance; MDR and MDV Reporting
- Drug Master File Development and Management
- Surveillance of Global Issues Effecting Industry
- Drug and Device Facility Inspections Support, Mock PAI audits
- FDA PMA Panel Preparation & Dispute Resolution
- Q-submission Briefing Document Preparation and Training
- EP Certificate of Suitability (CEP)
CLINICAL RESEARCH
- Clinical Studies Management, GCP, ICH
- Study Design Protocol, CRFs Development
- Clinical Supply Management
- Label Control & Translations
- CRO Management for Feasibility or Phase 1 studies
- Preclinical Testing Coordination, GLP
- IDE Progress & Final Report Writing
- Design of Pilot, Pre-market & Post-market Clinical Trials
- Clinical QA Compliance Audits
- GCP Documentation and Training
REGULATED INDUSTRY EXPERIENCE
- Combination Products Submission and Compliance
- Medical Devices, Drug, Biologics, IVDs
- FDA Class II and III, Sterile, Implantable Medical Devices
- Fermentation, Microbiology, Mammalian & Bacterial Cell Culture
- GMP, Q7, QSR, GCP, GLP, ISO Compliance Audits
- Cardiovascular, General Surgery, Wound Therapy, Urologic, Radiologic Imaging, Dental, OBGYN, Orthopedic, IVD Equipment, Robotic Equipment, SaMD, Mobile Medical Applications
QUALITY SYSTEMS
- QSR/GMP Quality System Development, Design and Writing
- Combination Products Gap Analyses and QS audits
- Internal and Supplier QS/GMP Audits, Onsite and Remote
- Sterilization, EtO, Gamma Irradiation Validation
- Biocompatibility/ Chemical Characterization Assessments,
- Complaint Handling and eMDR & Vigilance Reporting
- Training Programs: Executive C-level training, employee general and customized QS/GXP training
DEEP ROOTS COME FROM A DEEP NETWORK
The success of Canopy Regulatory projects results from having an established process for evaluating and assessing projects and its seasoned team of independent consultants and the collaborations with our partner groups that we have worked with over the years and trust to deliver high-quality work product.
PARTNER GROUPS
Design engineering firms
CROs
CMOs
Project management professionals
Operations and production specialists
Preclinical research organizations
Marketing organizations
Biostatisticians
Toxicologists
Systematic Literature Research
Clinical software management
PARTNER GROUPS
Design engineering firms
CROs
CMOs
Project management professionals
Operations and production specialists
Preclinical research organizations
Marketing organizations
Biostatisticians
Toxicologists
Systematic Literature Research
Clinical software management
INDUSTRY ORGANIZATIONS
Our team is engaged and actively participate in the industry and have had long term relationships or leadership roles in the following organizations:
Regulatory Affairs Professionals (RAPS), Twin Cities Ch.
MN Life Sciences Alley
America Society Quality (ASQ)
Parenteral Drug Association (PDA)
World Medical Device Organization (WMDO)