Clinical Trial Research. Research and Development. Medical Device Research

Our services Highlights:

We are an established Project Management Consulting firm. We are Regulatory Professionals with Specialization in Project Management. We have an extensive expertise in Project Management, Good Laboratory Practices, Good Clinical Practices and Good Manufacturing Practices.
We provide drug and medical device research and development lifecycle management from discovery and development, we offer GLP practices, Laboratory Project Management, Regulatory Submissions, Clinical Trials Management, Site Selection, Auditing and Monitoring of Clinical Research sites and GMP Sites.
We provide services to Startup's, Vendors, CRO and Sponsors in Pharma, Biotech, CDMO, CMO, CRAMS etc.

We offer validation and other related life science consulting services to pharmaceutical, biotechnology, and medical device industries. We also have a team of project managers who are PMP certified with experienced in clinical trial services and management. Our Project Management Consulting services includes;

Drug and Medical Device development projects.
Clinical Trial Auditing and Monitoring.
Quality Assurance / Quality Control.

Medical Device PM, Calibration and Qualification.
Comprehensive US FDA Regulatory and Submission Strategy.
Novel Device classification.
Identification of Predicate Device for Substantial Equivalence Analysis.
Gap Analysis as per US FDA regulation and international standards.
Compilation of all sections of 510(k) Technical File in eSTAR format.
Investigational New Drug (IND) submission.
New Drug Applications (NDA) submission
All other FDA Submissions.
Investigational product manufacturing process validation.
Computer & Data Validation.
Equipment Validation (IQOQPQ).
Facility Validation.
Protocol design and SOP development.
FDA Regulatory guidelines and many more.........

Medical Device Preventive Maintenance

Are you a startup, an established medical device, or drug research, development and manufacturing organization? Do you have an idea for a medical device, or a new drug? Do you need a project management team with regulatory subject master expertise? Do you need help figuring out how to sell your product in US or International market? or do you simply need help managing your equipment servicing, installation, qualification etc.?

We are the Regulatory Project Management and Engineering team you need. Let us help you.

We offer regulatory submission project management consulting guidelines.We provide Project Management consulting services to Pharma and Biotechnology clients. We managed all regulatory compliance process. We assist our clients throughout the entire lifecycle of Drug and Medical Device Research, Development, Manufacturing and Servicing.

Clinical Research, Development, Manufacturing, Servicing and Documentation Project Solutions.

Discovery & Development
Medical Device Development
Drug Development
Good Laboratory Practices
Pre-Clinical Research
Clinical Research Project Management
Clinical Data Validation
Clinical Development
Site Selection
Clinical Research Monitoring
Post-Market Monitoring
Good Manufacturing Practices
GMP facility oversight
Drug manufacturing oversight

Regulatory Submission Roadmap
Clinical Research Solutions
R&D Technology
Quality & Compliance
Pharmacovigilance
Novel Device classification
Substantial Equivalence Analysis
Therapeutic Areas
GMP Services:
Process validation oversight
Equipment Validation
IQOQPQ
SOP development.
Computer & Data Validation

TEDMED Engineering Projects (TMEP Consulting)