Anson Group provides service options to Clients that apply across the broad range in medical technology product development, from planning, through pre-clinical and clinical validation, to market approval and post-market compliance.  How can you, as a potential Client, know whether you might need our help?  Answers to the questions like these below can tell you fairly quickly whether or not Anson might be able to help you with a product commercialization or process compliance issue.
 

1. Are you currently contemplating the launch of a healthcare product to the market but are unsure of its regulated status?  Do you wonder what impact the decision to launch a healthcare product might have on your non-medical/unregulated operations? Click to expand +

If you think your healthcare product fits one of the legal definitions shown below, it is likely to be regulated by FDA in the United States.  Anson can help you with strategies and services to gain marketing approval through the least burdensome approach.

• Drug Click to expand +

“… articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and

… articles (other than food) intended to affect the structure or any function of the body of man or other animals; and

… articles intended for use as a component of any article specified” in the preceding clauses. 21 U.S.C. 321(g)(1)
Our Services for Drugs & Biologics

• Biologic Click to expand +

“… a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide) or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.”  42 U.S.C. 262(i)(1)
Our Services for Drugs & Biologics

• Device Click to expand +

“an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is:

… intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

… intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.”  21 U.S.C. 321(h)
Our Services for Pharma & Medical Devices

• Combination Product Click to expand +

“A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity;

Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products;

A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose; or

Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.” 21 CFR § 3.2(e)
Our Services for Pharma & Medical Devices

2. Are you new to the healthcare industry and unfamiliar with FDA requirements? Click to expand +

As a company new to medical technologies, you will find yourself navigating through a complex web of business and regulatory processes. Anson can provide you with a broad range of services across the product development spectrum to help you move through the web, including registering you as a drug, biologics, or device manufacturer with FDA, providing assistance with planning and/or conducting animal and/or clinical trials (or developing an out-source strategy for such testing), and developing a compliant manufacturing quality system.  If your company is a start-up, Anson can also assist you with your fund-raising process through business plan development activities needed to gain grant or venture capital funding.

3. Are you contemplating an investment, acquisition, or sale of another company or division of a company with regulated technology, but are unsure of their level of compliance? Click to expand +

Anson provides compliance assessment and remediation services, as well as due diligence services focusing on regulatory compliance.  If a company’s design control, change control, adverse event reporting, and other procedures do not conform to FDA requirements and/or are insufficiently documented, Anson can help design and implement corrective actions without compromising those business processes that are working well and are in control.

Our Services for Pharma & Medical Devices

4. Are you an established medical device, drug, or biologic product manufacturer who requires co-sourcing support to augment your internal regulatory and/or quality resources? Click to expand +

Anson can provide a long-term support arrangement focused on your most critical needs.  We can provide a broad range of support services, including direct advisory support to senior management for quality system issues; periodic quality assurance auditing and follow-up training programs; advisory support to key middle management personnel; and assistance to deal with inspections and serious FDA compliance issues.  Anson can also assume the role as your FDA correspondent and liaison, including support for both new product approval submissions and mandatory reporting.

Our Compliance Expertise

5. Do you need assistance with developing a regulatory submission or with meeting with FDA to discuss your product? Click to expand +

Anson can help you develop and implement a development plan to advance your product through clinical trials, including planning and submitting the IND or IDE that is required before you can begin human clinical trials.  Anson can provide you with a wide range of drug development services including project management, clinical study design and planning, investigational site management and monitoring, and data summary and presentation.  In addition, Anson can serve as your liaison with FDA for regulatory issues management and represent you in meetings with the Agency throughout the development process.  Anson can prepare and submit the NDA, BLA, 510(k), or PMA for you and continue to represent you with FDA in order to achieve a successful product approval or clearance.

Our Compliance Expertise

6. Do you require assistance with GLP-compliant preclinical scientific research requirements or with GCP-compliant clinical study design? Click to expand +

Anson can help you develop and implement a development plan to advance your product through clinical trials.  Anson can provide you with a wide range of drug development services including project management, assistance with planning and/or conducting animal (preclinical) toxicology and pharmacokinetics studies, clinical study design and planning (including protocol development), case report form (CRF) review, investigational site management and monitoring, and data summary and presentation.

Our Commercialization Expertise

7. Do you need assistance for product design control processes, hazard analysis, quality systems development, or software validation and verification methodologies? Click to expand +

In addition to performing compliance audits of your quality system that may reveal correctable procedural and training problems, Anson can develop long- or short-term support arrangements focused on your most critical needs and that adjust as your compliance status improves.  Our support can include direct advisory support to senior management for risk assessment, corrective actions, and resource allocation; periodic quality assurance auditing and follow-up training programs to assist with remediation efforts; advisory support to key middle management personnel; and immediate assistance to deal with inspections and serious FDA compliance issues.

Our Compliance Expertise

8. Do you have compliance concerns regarding your post-market clearance or approval responsibilities? Click to expand +

Anson can audit your manufacturing and reporting processes and develop a corrective action plan to improve your compliance with regulatory requirements.  We also provide a range of remediation services, including direct employee compliance training and ‘Train the Trainer’ training to provide you with the resources for ongoing recognition and correction of compliance issues.

Our Compliance Expertise

9. Has your company received an FDA Warning Letter or Notice of Inspection, and you would like an outside expert perspective? Click to expand +

Anson can develop support arrangements for you that are focused on your most critical needs and that can adjust as your compliance with FDA regulations improve. This support can include direct advisory support to senior management for risk assessment, corrective actions, and resource allocation; periodic quality assurance auditing and follow-up training programs; advisory support to key middle management personnel; immediate assistance to deal with inspections and serious FDA compliance issues; and assuming the role as your correspondent and liaison with FDA.  As remedial actions are implemented, Anson can perform compliance audits of your quality system to reveal any additional correctable procedural and training problems that might provide impetus for further FDA actions.

Our Compliance Expertise