Drugs

 

EAS is a leading provider of regulatory consulting services to the pharmaceutical industry with over 50 years of experience assisting clients in developing regulatory strategies, implementing quality assurance programs, filing regulatory submissions and ensuring compliance with FDA regulations. Our expert consultants have advised companies on FDA pharmaceutical policies and procedures, including interpreting FDA policy and guidance documents related to cGMPs. We provide valuable assistance in the preparation of SOPs for complaint handling, recalls, change control, ISO Quality Systems, employee practices, failure investigations. In addition, our expert toxicologists review Chemistry and Manufacturing Control (CMC) submissions to FDA for completeness and accuracy.EAS auditing services to the pharmaceutical industry include cGMP, Quality System and pre-approval audits of manufacturers, laboratories and vendors, due diligence for M&A and insurance assessments, as well as “FDA mock inspections” to help firms prepare for FDA pre-approval inspections.

In addition, EAS assists with guidance on import procedures and obtaining clearance of products through U.S. Customs and FDA at time of entry.

EAS provides expert and thorough consulting services for all of your pharmaceutical, OTC, homeopathic, allopathic, compounding and generic needs.

Drug Labeling and Claims

EAS’ labeling staff is highly experienced in requirements for pharmaceutical labels. With our detailed knowledge of FDA labeling requirements, we can review your label for formatting and claims and advise you on how to be in compliance.

In the case of Over the Counter Non-Prescription Drugs, or OTCs, the product must be presented using the standardized Drug Facts format and content layout which allows consumers to better read and understand how to safely and effectively use the product. These requirements are applicable to all OTC drug (including homeopathic) and OTC drug cosmetic products, whether marketed under an OTC drug monograph or an application.

Our labeling experts guidance includes labeling of homeopathic and conventional allopathic drugs; ensure that the structure/function claims are appropriate whether your product is a drug or a dietary supplement, and identify when both cosmetic and drug claims can be included in labeling certain products.

EAS Consulting Group assist companies with the design and format of all pharmaceutical product labels. Our consultants, with both FDA and industry experience, understand the complexities of labeling regulations and ensure compliance.

Submission of New Drug Applications and Abbreviated New Drug Applications

EAS can assist with all pharmaceutical submissions and amendments to FDA and Health Canada. Our scientific experts in toxicology, radiology, chemistry, and biology are authorities in government laws and regulations. EAS can lead your company through the process of obtaining necessary background data, filing the submissions, and following-up as needed during the submission process.

NDA, or New Drug Applications: Drug sponsors may petition the FDA for approval of a new pharmaceutical for sale and marketing in the U.S. through a New Drug Application using the data gathered during the animal studies and human clinical trials. Via a 505(b)(2) application, the NDA allows the usage of agency findings for a previously-approved drug and published literature and allows the FDA to determine whether the benefits of a drug outweigh the potential risks, whether the proposed packaging and insert is appropriate and whether manufacturing methods allow for adequate preservation of identity, strength, quality, and purity.

ANDA, or Abbreviated New Drug Applications (for Generic drugs) are “abbreviated” because they are generally not required to submit preclinical and clinical data to establish safety and effectiveness. Instead, generic applicants must demonstrate bioequivalence, or identical in active ingredient, dosage form, strength, route of administration, labeling, quality, performance characteristics and intended use, among other things, to a previously approved reference drug.

EAS Consulting Group assists clients with filing drug applications. Our Senior Director of Drug and Device Services works with our team of drug application experts to determine the best course of action, designs the studies necessary to support this, and files the application and/or any subsequent supplements on the clients’ behalf.

Submission of Drug Master Files

EAS can assist with all pharmaceutical submissions and amendments to FDA and Health Canada. Our scientific experts in toxicology, radiology, chemistry, and biology are authorities in government laws and regulations. EAS can lead your company through the process of obtaining necessary background data, filing the submissions, and following-up as needed during the submission process.

A Drug Master File (DMF) submission provides detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. The information contained in the DMF may be used to support an IND, NDA, ANDA, another DMF, an Export Applications.

For more information on Drug Master Files, view our White Paper written by EAS Independent Advisor, Albert Yehaskel.

Submission of Investigational New Drugs

EAS can assist with all pharmaceutical submissions and amendments to FDA and Health Canada. Our scientific experts in toxicology, radiology, chemistry, and biology are authorities in government laws and regulations. EAS can lead your company through the process of obtaining necessary background data, filing the submissions, and following-up as needed during the submission process.

IND or Investigational New Drug Applications are required for all new molecules that are eventually intended for use in human pharmacology products and have already been screened in animals. Once the legal status is changed to INDA under the FD&C it requires an application process which includes preclinical data which shows the product is safe for testing in humans; information on the manufacturer, composition and stability for manufacturing as well as protocols which will be used in the clinical studies to assess whether subjects will be exposed to unnecessary risks.

Submissions for Over the Counter Drug Products

EAS Consulting Group develops filing submissions and responses to Agency initiatives concerning OTC drugs, monographs, and petitions to request a specific change to a monograph.

Rx to OTC Switch, or Direct to OTC NDA: There are two regulatory pathways through which OTCs can be legally marketed – OTC Drug Monograph or New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). In all cases, the products must be manufactured in FDA-registered facilities and electronically submitted in FDA’s Drug Registration and Listing System. EAS Consulting Group can assist your company in understanding and comply with the requirements applicable to OTC drug monographs, the NDA or ANDA application process, homeopathic drug marketing, as well as facility registration and drug listing submissions.

Citizen Petitions: A Citizen’s Petition is used to request a change to a monograph at any phase of its development, but can only be used for ingredients that would have been eligible for inclusion in the original monograph (i.e., were marketed for the same purpose prior to 1972 when the OTC Drug Review process began). Through a Citizen Petition (CP) Process, the FDA can be petitioned to amend a drug monograph either during development or after final publication. For the petition to be considered, submitted data must include information that demonstrates that a product is generally recognized among scientific experts as safe and effective.

OTC Time and Extent Applications: The TEA is used for OTC drug products marketed under certain conditions “to a material extent” and “for a material time” and generally applies to products marketed under an NDA in the U.S. after the OTC Drug Review process began, or have only been marketed outside of the U.S.

Drug Recalls

A product recall is a time-consuming and expensive endeavor but is required whenever a regulated product is found to be either defective or potentially harmful. While drug recalls are generally caused by a failure of a product to meet FDA regulations, the FTC may request a recall if label or website claims do not meet appropriate levels of substantiation, or the CPSC may determine that a product’s packaging is not in compliance. Whether the recall is voluntary or requested by these agencies, the recalling firm must have a procedure in place to ensure all violative product is removed from the marketplace.

From ingredient/component suppliers to manufacturing /processing/labeling, to the distribution of the products within the U.S. market, firms should take a proactive approach to ensure the safety of their product and reduce the potential for a recall. EAS can assist with the performance of a mock recall to assess your readiness to execute an actual recall.

In the unfortunate event of a recall, EAS consultants can advise on the recall process to ensure compliance and act as a conduit of information between your company and the FDA. or other government agency.

Import Entry Assistance

EAS offers import entry assistance for foreign firms whose products are in detention. Our consultants work with FDA and Customs Border Patrol to determine the reason for detention and assist clients in developing and executing a remedy allowing for the expedited release of affected products. Working as a foreign company’s US Agent, EAS offers the best in regulatory solutions for your most pressing import needs.

US Agent and Product Listings

EAS Consulting Group provides registration and listing assistance as well as US Agent services to international clients in all FDA regulated areas. US Agents are required by FDA to act as an intermediary between foreign firms and FDA. By quickly responding to questions and concerns in a timely manner EAS helps clients get their compliant products to the U.S. marketplace as quickly as possible.

As your US Agent, EAS will file your behalf any product submissions and amendments as well as facility registrations.

483 and Warning Letter Responses

In the event that FDA issues a 483 or warning letter or the Department of Justice files a consent decree, EAS can assist with a timely and appropriate response. EAS also assists as a third-party expert for review, audit, and evaluation of facilities and documentation, and can formulate a remediation plan and response in compliance with FDA requirements.

Foreign Facility Inspections

FDA must be permitted to inspect the facility at any time in accordance with the FD&C Act to determine compliance with FDA regulations for safety and to identify any potential problems before the products enter the U.S. marketplace.

EAS Consulting Group is available to provide a mock FDA inspection of foreign facilities to determine deficiencies and/or to develop a corrective action plan either before FDA makes its initial inspection or if FDA finds deficiencies that need correction.

Pharmaceutical Good Manufacturing Practice Regulation Audits

FDA ensures the quality of pharmaceuticals in the US marketplace through a system of Good Manufacturing Practices (GMPs), a system it takes very seriously. These GMPs provide a standard by which all pharma companies must operate, from handling raw materials, the safety and security of the facilities to testing and validation of equipment and product which together helps to prevent contamination, mix-ups, deviations, failures, and errors. While drug GMPs are a standard across the industry, understanding how to apply them in each setting is unique as each company is able to determine how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures suitable for their business.

EAS consultants offer the best in Drug GMP compliance audits and facilitate an understanding of how to implement quality programs that meet FDA expectations.

Conducting Due Diligence and Contract Partner Audits

EAS is staffed with former FDA investigators and industry auditors that are available to audit firms that are being considered for acquisition or investment or which are being considered as a potential contract manufacturer, packager, distributor or testing laboratory. EAS can perform due diligence audits that will assess their current level of compliance with FDA GMPs and other regulations and identify potential quality and regulatory risks and gaps. By having EAS on the due diligence team regulatory and compliance risk can be minimized.

Reviewing Laboratories for Compliance with GLP and GMP Requirements

Good Laboratory Practice (GLP) and Current Good Manufacturing Practice (GMP) requirements for pharmaceutical laboratories encompass requirements for the laboratory’s physical facility and environment, quality agreements with lab contractors; the accuracy of instrument calibration and maintenance programs; computer systems; samples and sampling schemes; microbiology practices and procedures; lab SOPs and more. The importance of these schemes for obtaining and reporting credible analytical results leading to a safe and effective product is paramount to the supply chain’s success.

EAS consultants are experts in GLP and GMPs and offer review audits of contractor and supplier laboratories to ensure compliance with required components of each. Our assessment reports allow for a complete understanding of all component areas, a GAP analysis and recommendations for improvements to return to standards.

OTC to Cosmetic Switch, Homeopathic, Allopathic

Over-the-counter (nonprescription) drug products are medicines considered safe and effective for use by the general public without the necessity of first seeking treatment from a health care provider.They are either marketed as OTC drug monographs, categorized by therapeutic classes and providing a “recipe” for allowable active ingredients, dosages and labeling. Products that meet the requirements of an OTC drug monograph do not need FDA preapproval prior to marketing. OTCs may also be considered through an Rx to OTC switch.

In addition, homeopathic medicines may be marketed over-the-counter provided they are indicated only for self-limiting, self-diagnosable conditions and meet the requirements outlined in FDA’s Compliance Policy Guide Sec. 400.400.

Structured Product Labeling – Establishment Registration and Product Listings (SPL)

The SPL is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a way to exchange product and facility information for the pharmaceutical establishment and product registration. Drug establishments are required to register via their D-U-N-S number and maintain current drug listing information which is to be submitted electronically unless a waiver is granted, otherwise, they are considered to be misbranded. FDA requires that the establishment registration is renewed every year between October 1 and December 31st. Also, FDA requires that foreign establishments have an appointed US Agent for which EAS can serve.

EAS Consulting Group provides a number of services related to SPL registrations including preparation and submission of the SPL establishment registration, product listing (Rx, OTC, Homeopathic drug products), Labeler Code Requests and GDUFA Self-Identification files. EAS can submit these files to the FDA via their secure Electronic Submissions Gateway Account.

eCTD (Electronic Common Technical Document)

FDA requires all New Drug Applications (NDAs), Abbreviated NDAs (ANDAs), and Biologics License Applications (BLAs), must be submitted using eCTD format. It is FDA’s intent that submitted data be both compliant and useful for their reviewers. In FDA’s words, the data should conform to the applicable and required data standards.

EAS provides eCTD writing services and can assist your company in submitting eCTDs. Once a submission is compliant with FDA requirements, EAS may submit the file on your company’s behalf, or return the final product for self-submission through the FDA gateway.

Please contact EAS with your eCTD questions. As always, EAS is available to review your submissions prior to sending to FDA to ensure compliance and completeness, expediting FDA’s review.

Pharmaceutical Employee and Management Training

EAS is frequently requested to bring our popular public training programs in-house, offering a dedicated training for employees and customizing the content as-needed to focus on specific areas of need. Popular in-house training programs for the pharmaceutical industry include:

  • OTC GMP Compliance Review Seminar
  • Marketing and Labeling OTC Drugs OTC Drugs and Cosmetics in Compliance with FDA Regulations
  • Drug GMP Compliance Review
  • Preparing for FDA Pre-IND Meetings – Steps for Success
  • Pre-FDA Inspections – Preparation, Validation, Qualification

Or join us at one of our upcoming training programs coming to a city near you.

Expert Witnesses in Legal Cases

In the industries regulated by FDA, such as those in the pharmaceutical, medical device, food, dietary supplement, and cosmetic business, compliance issues are of great importance. When disputes arise, the regulatory compliance status of a product or facility is often a key issue and can make a significant difference in how the matter will be resolved. In such cases, it is critical to have the assistance and advice of experts who are both experienced and knowledgeable in FDA regulations and industry practices, and who will be perceived as independent and objective. Whether a dispute is resolved via mediation or litigation it is imperative to have a well-respected and knowledgeable expert witness acting on your company’s behalf. EAS independent advisors and consultants are routinely called to serve as expert witness in a variety of cases and provide the in-depth, detailed attention required in these cases.

EAS offers one of the most experienced groups of consultants available on FDA regulatory compliance issues. We offer a team of former high-level FDA officials and industry professionals who will share their expertise with our clients. Our consultants have an average of over 25 years of regulatory experience and include some of the most well-known and highly respected names in the industry. As new standards and regulations proliferate, EAS keeps abreast of the changing regulatory landscape, allowing us to deliver up-to-the-minute policy advice to our clients. Our experts have the knowledge, qualifications, and experience necessary to explain and clarify the issues to our clients and the courts while establishing credibility and persuasiveness as witnesses.

EAS offers assistance in adjudicating insurance claims and servicing as an expert in depositions and civil litigation cases. With high-level experts in all areas of FDA regulations, EAS is well recognized as representing the industry in all manner of court cases.