Atlantic Consulting can design an appropriate plan to simplify procedures and provide technical writing for your applications. 

Atlantic505 Consulting

Atlantic Consulting can immediately execute your  regulatory and compliance program needs.

TESTIMONIALS

IMPLEMENT

Atlantic Consulting can evaluate your current risk and propose a new planning strategy to begin implementation.

​Bring the FDA Regulations into Prospective 

"Scott teaches you to think, what is the purpose of this document and who is it going to or to be utilized by". 

Venkata Gogineni, PhD,  QA Consultant

"Scott has an incredible talent to solve regulatory and compliance issues, no-one will go wrong by approaching him for your consulting need"

Shashibhushana Raju, Quality Director

OUR SERVICES

Email: scott.groner@atlantic505.com

ASSESSMENT

PLANNING

Provide consultation, development, and review services for:

• 505(b) or 505(j) Submission:

Provide PIND meeting requests and packages, IND submission ready applications, DMF submission ready applications, PNDA meeting requests and packages, NDA submission ready applications, and ANDA submission ready applications. Important to focus on different aspects between NDA and ANDA applications (sterile & non-sterile).

 US Agent availability for foreign manufacturer facilities and establishment of electronic submission capability according to eCTD -

• BA/BE Study Protocol Development & Monitoring:

Provide recommendation for BA/BE study site, protocol development, and on-site study monitoring during BA studies.  

• Product Manufacturing Changes & Supplement Submission:

Manufacturing changes are unavoidable and making the correct assessment and supplement submission planning can bring supply chain back on schedule. 

• Product Complaints & Pharmacovigilance Program:

Drug product approval and product launch have mandatory post-approval commitments, such as a product complaint program with well-defined procedures and adverse event pharmacovigilance program design based on system organ class. 

• SOP Development for R&D & Manufacturing: 

Depending on company size, goals, and upcoming approvals; SOPs can be developed and implement differently. The most important function of SOPs is to provide easy to follow procedures that do not slow down R&D or Supply Chain.

• GMP Audits - R&D, API, CRO, eCTD, PAI, MFG, CMO, & DEA Groups:

An effective on-site data integrity audit gives a proper assessment on were a company stands. Every company regardless of should have an independent risk assessment whether for partnership of new drug launch, API facility readiness, clinical study site capability, application readiness, pre-approval readiness, manufacture controls for handling deviation and laboratory investigations (including any outside contract firm), product release assessment, and controlled substance accountability.          

Data Integrity Audits depending on the overall risk should be performed at the raw data entry notebook level or can be performed based on current managerial planning. Provide independent PQA (Product Quality Assessment) and CEP (Compliance Enhancement Plan) reports to District Office.