Regulatory Strategy

Our goal is to provide pharmaceutical developers and manufacturers with sound regulatory strategies to facilitate market approval and delivery, in a timely and cost-effective manner. Compliance Gurus can provide pharmaceutical organizations with a comprehensive plan to ensure adherence to the requirements of the Federal Food, Drug and Cosmetic Act and FDA regulations/guidances.

We offer guidance on all aspects of the product development lifecycle, from pre-submission planning, through post-market evaluation and reporting.

Pre-submission services include, pre-IND planning, product classification & designation requests, clinical trial design & protocol review to support marketing objectives, CMC design and implementation, briefing book compilation, labeling, and packaging guidance.

Post-marketing surveillance services include, drug tracking & tracing design and implementation, product complaint design, product safety evaluations and adverse event categorization and reporting.

In addition, we are happy to assist domestic and foreign pharmaceutical manufacturers, repackers, and relabelers that engage in the manufacture, preparation, propagation, compounding, or processing of human or veterinary drugs, with FDA drug establishment registration, and distributed product listing.


After an extensive search, we have retained the services of the most prominent and experienced pharmaceutical submission specialists, in the country. We are proud to offer IND (Investigational New Drug Application), NDA (New Drug Application), and ANDA (Abbreviated New Drug Application) submission, FDA meeting and negotiation services.

Advertising & Promotion

Advertising and promotional services include, the review and analysis of multimedia (DTC, print, website, social media) post-marketing materials, to ensure a “fair balance” of risks & benefits, and compliance with FDA and PhRMA code advertising & promotional regulations and guidances.

Our professionals have extensive experience with evaluating promotional claims, including comparative, efficacy, superiority, indication, and reminder, help-seeking advertisements.

In addition, we can also assist with OPDP Form FDA-2253 submissions for drug labeling and advertising review.

cGMP (current Good Manufacturing Practices)

The Food, Drug and Cosmetic Act mandates all pharmaceutical manufacturers, processors, packagers and holders, labelers, to comply with good manufacturing practices. Compliance Gurus can update and improve your existing quality management system, in conformance with contemporary, 21 CFR 210/211, regulatory requirements and FDA/ICH guidances. In addition, we are experienced at developing and implementing streamlined, cost-efficient quality plans for small businesses and start-ups.

Part 11

Medical device organizations utilizing electronic systems to create, modify, maintain, archive, retrieve or transmit data records, mandated by the Federal Food, Drug and Cosmetic Act or FDA regulations, must comply with 21 CFR 11. Part 11 also applies to recordkeeping measures, which assign electronic signatures. Compliance Gurus can conduct a Part 11 assessment of your company’s electronic records and signatures, and revise or implement a compliant Part 11 protocol.

Computer System Validation

Compliance Gurus can assist your organization with your computer system validation needs.
We are experts at qualifying infrastructures and validating computerized systems, ranging from small desktop applications, through enterprise-wide applications deployed for global use. Furthermore, our staff has substantial experience validating a variety of GLP, GDP, GCP, and GMP systems and software applications.


The Compliance Gurus team are experts at auditing internal and external regulatory systems, processes and procedures. Whether you are preparing for an FDA Pre-Approval Inspection, have received a FDA 482: Inspection Notice, or want to perform an FDA mock audit, as part of your inspection readiness plan, we can assist you. We can provide a detailed, comprehensive gap analysis of your company and vendor regulatory requirements, to identify compliance related deficiencies. Upon discovery, regulatory gaps will be analyzed, from a risk management perspective, and can be addressed through the implementation of a corrective and preventive action plan.
Our auditing services span the entire pharmaceutical product development and quality management lifecycle. We frequently audit 3rd party vendors, including facilities, contract research organizations, contract manufacturing organizations and contract packaging organizations.


Compliance Gurus can provide employee training to small and large groups. All of our corporate trainers possess advanced degrees and have ample years of experience working in the FDA regulated industry. Pharmaceutical organizations can customize their educational curriculum, by choosing from our comprehensive selection of FDA and pharmaceutical related content.

Currently, our training topics include: FDA History, The Organization of the FDA, History of Pharmaceutical Regulation, Good Manufacturing Practices for Pharmaceuticals, Pharmaceutical Advertising & Promotion, and Current Trends in Pharmaceutical Regulation.

FDA Interaction and Remediation

Direct interaction with the FDA is a stressful, apprehensive experience, even when conducted under the best of circumstances. Compliance Gurus is available to alleviate your corporate anxiety, by offering support during this challenging time. If you are preparing for a Pre-Approval Inspection or have received a Form 482: Notice of Inspection, we can prepare you for the audit by providing pre-inspection guidance. In addition, we are available to accompany you, during the inspection, to help mediate any points of contention between the parties.

Compliance Gurus offers comprehensive remediation services for organizations receiving a Form 483 or Warning Letter, after FDA inspection. We can structure and implement an effective remediation plan to efficiently address any compliance deficiencies or violations. If your company has received a Warning Letter, we can author a satisfactory Company Response and devise a corrective action plan, in adherence to the 15-day response timeline.

In addition, our consultants are available to assist corporations with the logistics, which may arise from a voluntary or FDA mandated product recall.