Services
Strategic regulatory
solutions
From initial consultations to comprehensive regulatory strategies, we offer tailored
solutions to meet your specific needs. Our services include:
Strategic regulatory
Navigating regulatory
complexity
Unlock the path to FDA approval with our expert
guidance. Our seasoned consultants leverage over
25 years of experience in Pharmaceutical
Regulatory Affairs to steer your product through
the intricate maze of FDA regulations.
Strategic solutions for
success
Crafting a winning regulatory strategy requires
foresight and precision. Our team (currently me), comprised of
industry veterans from major US pharmaceutical
companies, develops customized plans aligned
with your unique product and business goals.
Ensuring regulatory
compliance
Stay ahead of regulatory changes and maintain
compliance with FDA standards. Our consultancy
offers comprehensive support, from document
preparation to regulatory submission, ensuring your
product meets all necessary requirements.
Abbreviated new drug application (ANDA): An Abbreviated New Drug Application (ANDA) is a regulatory submission to the FDA for the approval of a generic drug. Unlike a New Drug Application (NDA) for new drugs, an ANDA is for generic versions of existing brand-name drugs. The applicant demonstrates bioequivalence to the reference-listed drug (RLD), ensuring the same therapeutic effect. The ANDA includes data on active ingredients, dosage form, strength, labeling, and manufacturing controls. Once approved, the generic drug can be marketed in the US as a cost-effective alternative to the brand-name drug, increasing access to affordable medications while maintaining quality and safety standards.
Authorized generics regulations: Govern the sale of a brand name drug as a generic, often at a lower cost, without a new drug application.
Certificate of pharmaceutical product (CPP): A certificate issued by the national regulatory authority of the exporting country that confirms the pharmaceutical product is authorized for marketing in that country and complies with good manufacturing practice standards.
Chemistry, manufacturing and controls (CMC)
Competitive generic therapies regulations: Encourage the development of generic drugs for products with inadequate competition, offering exclusivity incentives.
Controlled correspondence to FDA: A formal communication with the FDA by generic drug manufacturers seeking information on drug product development or post-approval submission requirements.
Controlled substance regulations (State and DEA): State-specific regulations in alignment with the DEA’s Controlled Substances Act, managing the use and distribution of controlled substances to prevent abuse while ensuring availability for medical use.
Device history file (DHF): Manufacturers must maintain DHFs demonstrating that the device is manufactured in accordance with the design master record (DMR) and the requirements of part 820.
Drug master file (DMF): is a detailed submission to regulatory authorities, containing comprehensive information on drug manufacturing processes, materials, and facilities. It aids in regulatory reviews by providing essential manufacturing and quality control data without disclosing proprietary information. DMFs facilitate efficient evaluation of drug safety, efficacy, and quality during regulatory processes. Additionally, they can be referenced by other companies for their own regulatory submissions, supporting the exchange of critical information while safeguarding proprietary data. Overall, DMFs are vital in the regulatory process for pharmaceutical products, enabling effective communication between manufacturers and regulatory authorities.
Due-diligence audits: Performing due diligence for mergers, acquisitions, and partnerships to assess regulatory risks and compliance status.
Drug product labeling: Provides essential information about a drug, including indications, dosing, and safety warnings in package inserts, medication guide, patient information leaflet, primary and secondary container labeling.
Drug recall procedures: A systematic approach to remove or correct marketed drug products that are in violation of the laws administered by the FDA.
Investigational new drug (IND): An Investigational New Drug (IND) is a submission to the FDA required before testing a new pharmaceutical product in humans in the US. It provides comprehensive information on the drug’s safety profile and proposed clinical trials to ensure human subject protection. The IND includes data from preclinical studies, drug chemistry, manufacturing details, and clinical trial protocols. Once approved by the FDA, the sponsor can conduct clinical testing. The IND remains active throughout the trial, with the sponsor reporting adverse events or new safety information. If successful, the sponsor may submit a New Drug Application (NDA) for FDA approval to market the drug for a specific indication.
New drug application (NDA): NDA stands for New Drug Application. It is a regulatory submission made to the U.S. Food and Drug Administration (FDA) when seeking approval to market and sell a new pharmaceutical product in the United States. The NDA contains comprehensive data from preclinical studies and clinical trials, as well as information on the drug’s chemistry, manufacturing, and controls. The purpose of the NDA is to demonstrate the safety, efficacy, and quality of the new drug, ensuring that it meets regulatory standards for approval. Once the FDA reviews the NDA and determines that the drug’s benefits outweigh its risks, it may grant approval for commercialization, allowing the new drug to be marketed and prescribed to patients in the United States.
OPDP regulations: Ensure that prescription drug advertising is truthful and not misleading, now overseen by the Office of Prescription Drug Promotion (OPDP).
OTC drug regulation: OTC drugs are developed under the OTC Monograph process or through the New Drug Application (NDA) process. The FDA ensures that OTC drugs meet quality, effectiveness, and safety standards.
Paragraph certifications: PIV and section VIII certification
Petitioning USP: Requesting the United States Pharmacopeia to establish or revise standards for medicine quality and consistency.
Post-approval activities (supplement filing strategy & life-cycle management): Involves marketing tactics for dietary supplements, emphasizing unique branding and clear messaging.
Pre-Launch activities importation requests (PLAIR): Allow for the importation of unapproved drugs by applicants anticipating FDA approval, streamlining the pre-launch process.
Product lifecycle management: Offering guidance throughout the product lifecycle, from initial concept to post-market surveillance.
Regulatory requirements for dosage forms: The FDA imposes specific requirements on various dosage forms to ensure safety, efficacy, and quality. These requirements vary depending on the type of dosage form. For solids like tablets and capsules, criteria include composition, manufacturing processes, stability, dissolution testing, and labeling. Modified release dosage forms must demonstrate release characteristics over time, undergo biopharmaceutical testing, and maintain consistent release profiles. Injectable forms are subject to sterility testing, particle size evaluation, compatibility checks with delivery devices, and container closure studies. Inhalation products need assessment for particle size distribution, dose uniformity, device performance, and microbiological quality. Semi-solids such as creams and ointments require scrutiny of active ingredient content, microbiological quality, stability under storage conditions, and container integrity. Solutions and suspensions must meet standards for chemical and physical stability, active ingredient homogeneity, particle size, and microbiological quality. Manufacturers must ensure compliance with FDA regulations and guidelines specific to their dosage form to obtain regulatory approval.
Regulatory affairs management: Managing all aspects of regulatory affairs, including correspondence with the FDA and post-marketing activities.
Regulatory strategy development: Crafting tailored strategies for drug development pathways, considering the regulatory requirements for different stages of product development.
Risk evaluation and mitigation strategy (REMS): is a formal plan required by the FDA for certain “riskier” drugs to ensure that the benefits of these drugs outweigh their risks.
Scientific and technical guidance: Supplying scientific and technical support for product development, including formulation, manufacturing, and testing.
State board of pharmacy licensing: Each state has its own Board of Pharmacy that regulates the practice of pharmacy and pharmaceutical manufacturers, wholesalers, distributors and third-party logistics providers (3PL), licensure of pharmacists, certification of interns, and registration of pharmacy technicians.
Suitability petition guidance: A suitability petition is a request by a drug sponsor (called the “petitioner”) to submit an abbreviated new animal drug application (ANADA) for a proposed generic new animal drug that differs from the reference listed new animal drug (RLNAD).
Therapeutic equivalence designations: FDA classifications that indicate a generic drug is equivalent to its brand-name counterpart in various aspects.
Training and education: Providing training sessions and educational materials on FDA regulatory policies, procedures, and updates.
US FDA agent: all foreign establishments must identify a US FDA agent while in the registration process. This is a mandatory requirement, and without US FDA agent, the registration cannot be completed. US PharmaReg LLC provides US FDA agent service to drug, API, and medical device establishments.
US FDA device regulation: Classification into Class I, II, and III with increasing regulatory control. Requirements include establishment registration, medical device listing, pre-market notification 510(k).
