LYF Research
“Promoting Drug Safety & Quality”
Pharmaceutical Testing Services from FDA and Health Canada Approved Labs
We provides testing services on samples of "clients and their competitors" from FDA Registered, or Health Canada accredited/ approved labs. We manage testing of:
Natural Health Products
Dermatological Preparations
OTC drugs
Container Closure System including:
Packaging Materials
Polymers & Plastics
Paints & Coatings
Rubbers & Latex
Site Establishment/ Licensing and Auditing Services
to facilitate approvals from FDA and Health Canada
The services include:
We act as Local Agent for FDA
Off-site audits
Facility Licensing/Registration with Health Canada/FDA
Product Licensing/Marketing Authorization
cGMP/GMP Audits for FDA/Health Canada inspection preparation
On-Site consulting
GAP Analysis
Generic Product Development & Regulatory Affairs Services
LYF Research helps the clients to plan and execute the regulatory requirements from the early stages of product development through to marketing authorizations.
Chemistry, Manufacturing and Control (CMC) is the most vital component of innovator and generic drug applications (NDAs and ANDAs). We specialize in product development supported by CMC services to make NDAs and ANDAs readily acceptable for any regulatory agency. In CMC we offer following list of services:
General Information
Manufacture
Characterisation
Reference Standards or Materials
Container Closure System
Stability
Description and Composition of the Drug Product
Pharmaceutical Development
Manufacture
Control of Excipients
Control of Drug Product
Reference Standards or Materials
Container Closure System
Stability
Business Establishment, Operation and Support Services (in USA and Canada)
We understand the limitation and concerns of our international clients regarding risks, initial cost, time, and process. We provide all the vital and secure business establishment services at competitive costs to our client to give them a boost from scratch to smooth operations of business operations. Our services include:
Business Registration (Company name and registration, preferably similar to name in country of origin)
Office location (Furnished with all amenities, Business address)
Office Operations Services ( Phone, Fax, Email, Mailing & Courier, Records, Web, Media)
Legalization Business (Trademark, Copyrights, Contracts, Bonds, Agreements,Deeds)
Financial Services (Bank Account, Accounting, budgeting, Loans, Grants, Tax Services)
Litigation Support Services
LYF has panel of Expert Witnesses who translate complex scientific data in a manner that is easy to understand within a courtroom, judicial forum, parliamentary committees, law enforcement or investigation agency, or even in technical committees or a boards. We can represent our clients in technical committees of the FDA, Health Canada, or other regulatory agencies.
We provide chemical litigation support and expert witness testimony in:
contamination analysis
contamination identification,
product failure (Out of Specification, Sub-standard, Counterfeit, Spurious)
product liability cases
personal injury, and
related cases requiring investigational analytical services.
