Education Program
Life Corp comprehensive regulatory services and wealth of industry experience ensure that clients can count on the expert advice & guidance as they navigate complex regulatory challenges. Life Corp specializes in product quality, manufacturing and compliance; pre-market submission to FDA and post-market compliance for medical devices, combination products, in vitro diagnostics; drug and biological products; food and dietary supplements, chemicals, beauty and personal care products; antimicrobials and biocides.
The Company's targeted regulatory services include:
- Strategic and technical guidance for medical product development and regulatory review
- Product quality, manufacturing (cGMP) and compliance
- Submissions: 510(k), Pre/Q-Submissions, PMA, 513(g) requests, HUD, HDE and IDEs
- FDA meeting preparation and communication
- Performance Testing requirements
- Submission Services for drug and biological products, chemicals & food contact notifications, antimicrobials and biocides
- Compliance Services
- Advisory services
- Medical product labeling, marketing and promotion
- Product lifecycle management
- Regulatory policy guidance
- Regulatory Strategy planning and communications
- Introduction to Principles and Practice of Clinical Research
- Principles of Clinical Pharmacology
- Ethical and Regulatory Aspects of Clinical Research
- Regulatory Aspects of Food, Drug, Biologics and Medical Device Submissions to U.S Food and Drug Administration (FDA).
- Chemical, Antimicrobial and Biopesticide submissions to U.S. Environmental Protection Agency (EPA)
Introduction to Principles and Practice of Clinical Research
MEDICAL DEVICES & COMBINATION PRODUCTS:
Life Corp delivers regulatory services to assist clients from early stage device/product development to marketing authorization and throughout a product’s lifecycle. The Company’s Medical Devices and Combination Products regulatory experts offer strategic and technical guidance in key areas, including FDA submissions, FDA’s review process and post-market requirements such as safety monitoring and quality systems. Life Corp makes this possible by applying extensive regulatory expertise, determining the best regulatory approach for a product and providing a comprehensive strategy to achieve a successful result.
Life Corp assists clients with all aspects of the regulatory review process for medical devices and combination products. Life Corp also assists with the medical device submission process, such as the preparation of 510(k)s and PMAs, 513(g) requests, de novo petitions and HUD, HDE and IDE applications.
Experts from Life Corp Medical Devices and Combination Products also provide advisory services that include extensive research and due diligence to firms engaged in potential mergers and acquisitions that require a regulatory risk assessment before and after a life sciences transaction.
MEDICAL DEVICE SERVICES
Product Lifecycle Management
- Strategic guidance on FDA’s regulatory process
- All aspects of product development
- Premarket review
- Post-market safety requirements
- Analysis of the market to identify potential competition
Premarket Submission Preparation
- Request for classification information (513(g))
- 510(k) Premarket notifications
- Premarket approval applications (PMAs)
- Requests for De Novo review of automatic Class III classification
- Humanitarian use designation (HUD) /Humanitarian Device Exemption (HDE) applications
- Investigational device exemption (IDE) applications
Premarket Review Process
- Scientific, medical and regulatory guidance for clinical programs and regulatory filings
- Strategic guidance and preparation for FDA meetings, including medical device advisory panel meetings
- Analysis of, and recommendations on, FDA communications
Marketing & Promotional Practices
- Strategic guidance on labeling requirements
- Promotional materials
- Direct-to-consumer advertising review processes
- Remediation of untitled and warning letters
Regulatory Policy Guidance
- Analysis of FDA policies and processes
- User fee requirements
- Medical device advisory panel meeting analyses
- Implementation of new FDA legislation, regulations, guidance documents and FDA standard operating procedures
Principles of Clinical Pharmacology
Our pharmaceutical services are dedicated to help you to overcome the challenges of drug development and manufacturing of both small molecule and biologic drugs. Life Corp provides solution with expertise that fits your unique needs for both pharmaceuticals and biopharmaceuticals. Our pharmaceutical scientists and regulatory experts would work with you at every stage of product development, providing a comprehensive and flexible regulatory service that would give you competitive advantage in the marketplace. Over the last 20 years our network of Good Laboratory Practice (GLP) and Good Manufacturing Practice (cGMP) professionals have provided high quality technical and regulatory services for some of the world’s largest and most innovative pharmaceutical companies.
Regulatory and Toxicology Consulting Services
Life Corp regulatory experts provide services, from bio/pharmaceutical discovery to commercialization through fast-track and cost-effective approach to allow you to gain market access for products and comply with FDA regulations.
Consumer Healthcare Clinical Trial Services
Life Corp offers clinical trial services for low risk investigational biologic, pharmaceutical products and medical devices that includes capabilities in dental, dermatology, podiatry and wound management specialist, led by experienced investigators. Our multi-disciplinary clinical research team provides robust clinical trial services compliant with ICH GCP and ISO 14155 to support your consumer healthcare, over-the-counter (OTC) medicine, and medical device product development.
Pharmaceutical Manufacturing Support Services
Life Corp manufacturing and regulatory support services include problem solving in research & development and manufacture of your drugs. You can rely on our years of research & development experience and global network of laboratories and specialists for regulatory support that’s second to none.
Ethical and Regulatory Aspects of Clinical Research
DRUG & BIOLOGICAL PRODUCTS
Life Corp Drug and Biological Products regulatory experts deliver a variety of regulatory services from the earliest stages of product development through post-approval commitments. Regulatory Services include monitoring and assessing the regulatory environment for emerging trends, analyzing the impact of agency actions on current development programs, and reviewing the competitive landscape for specific therapeutic areas.
Life Corp regulatory experts specialize in clinical trial design, FDA submissions and the review process, as well as post-market regulatory, safety or compliance requirements, including safety monitoring. The team’s regulatory approach is firmly grounded in established principles of public health practices and guided by decades of regulatory experience in drug and biological product development, spanning all therapeutic areas.
DRUG & BIOLOGICAL PRODUCT SERVICES
Product Lifecycle Management
- Strategic guidance on FDA’s regulatory process
- All aspects of product development
- Premarket review
- Postmarket safety requirements
- Analysis of the market to identify potential competition
Premarket Review Process
- Scientific, medical and regulatory guidance for clinical programs and regulatory filings
- Strategic guidance and preparation for FDA meetings, including advisory committees
- Analysis of, and recommendations on, FDA communications
Marketing & Promotional Practices
- Strategic guidance on labeling requirements
- Promotional materials
Regulatory Policy Guidance
- Analysis of FDA policies and processes
- User fee requirements
- Advisory committee analysis
- Implementation of new FDA legislation, regulations, guidance documents and FDA standard operating procedures
Regulatory Aspects of Food, Drug, Biologics and Medical Device Submissions to U.S Food and Drug Administration (FDA).
Food Contact Regulatory Services
Food contact regulatory requirements are complex for new food contact substances as well as compliance specifications for food contact materials. Food contact regulatory services are necessary to achieve compliance with global regulations concerning food contact materials and are also known as indirect food additives. These are materials that are intended to come in contact with food and are used in a broad range of applications including packaging, food processing machinery or equipment and household items.
The US Food and Drug Administration (FDA) regulates all components that are used in food contact applications such as various types of plastic or paper materials, as well as additives or colorants to be used in polymers to enhance strength, flexibility, and clarity or appearance, should be notified as per applicable FDA requirements. Furthermore, all final articles that are intended to come in contact with food and raw materials utilized to make these products that are to be placed in the market should be in compliance with US FDA requirements. Food contact materials are described in the Code of Federal Regulations (CFR), 21 CFR 174 - 21 CFR 190.
Life Corp food contact regulatory services would help you meet global regulatory compliance requirements and our services are delivered by industry experts. Our food contact regulatory compliance services include reviews, migration protocol development, third party certifications, and migration studies as per US FDA guidelines, placement and monitoring of toxicology studies to support the Food Contact Notification (FCN) submission.
Our FDA food contact regulatory services includes
- General guidance and interpretation of the Food Contact Regulations
- Consulting services for FDA food contact compliance and food contact notifications
- Preparation and submission of Food Contact Notifications (FCN) to FDA for new food contact substances
- Development of migration testing protocols and
- Conducting migration studies in order to support food contact notifications
- Liaising with the FDA during the submission process
Dietary Supplement Regulatory Services
Whether they are referred to as dietary or food supplements, natural health products, or complementary medicines, one thing is clear: with the increasing availability of such products, regulatory authorities are demanding greater standards of evidence to ensure that public has access to products that are safe, effective, and are of high quality.
Life Corp offers the regulatory and scientific and regulatory expertise necessary to provide reliable advice in the area of Food & Dietary Supplements and Natural Health Products.
Our Dietary Supplement Regulatory Services include
- Conducting feasibility assessments and, providing recommendations to meet regulatory requirements for safety, efficacy, and quality
- Compiling technical and scientific submissions to regulatory authorities, including new dietary ingredient notifications, product license applications, ingredient master files, and complementary medicines applications
- Providing product development support
- Assisting in the design, placement, monitoring, and management of clinical trial protocols for claim substantiation
- Preparing expert opinion letters
- Acting as a liaison with regulatory authorities during the submission review process
- Administering programs to meet post-market requirements, including adverse event reporting, regulatory monitoring, and surveillance programs
Chemical, Antimicrobial and Biopesticide submissions to U.S. Environmental Protection Agency (EPA)
US Cosmetics & Personal Care Product Regulatory Compliance Services
The United States Food and Drug Administration (FDA) is the legal authority regulating the cosmetic and personal care products in the United States. The FDA does not require cosmetic & personal care product pre-market approval, but the industry must comply with the Requirements of Specific Cosmetic Products (21 CFR § 700) regulations. Manufacturers are not required, at this point in time, to register products, ingredients, or supporting data, but are encouraged to submit their products to the FDA’s Voluntary Cosmetic Registration Program.
Cosmetic and personal care product labelling and labelling claims must comply with the regulations stipulated in the Food, Drugs and Cosmetics Act and the Fair Packaging and Labelling Act. The misbranded cosmetics and personal care products are illegal and may be the result in false or misleading labelling, failure to provide required information to the regulatory agency, improper display of label information may result in violation of the Poison Prevention Packaging Act.
Furthermore, the Safe Cosmetics Act of 2011 (also known as H.R. 2359) was recently introduced into the US House of Representatives on June 24, 2011 in response to growing concern among consumers and lawmakers about the safety of some ingredients used in cosmetics.
US Cosmetics & Personal Care Product Regulatory Compliance Services
Life Corp provide cosmetics and personal care industry with complete scientific and regulatory support for compliance with applicable United States Cosmetics Regulations to legally market their products on the US market.
- Cosmetic Safety Assessments
- Toxicological Risk Assessments (TRAs)
- Regulatory Compliance Support
- Voluntary Cosmetic Registration Program
- Regulatory consulting
- Design, placement, and monitoring of clinical studies for Claim Substantiation
- Product Labelling Review and Support