Regulatory Consulting

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Beckloff Associates is a full-service pharmaceutical research and development regulatory consulting firm that specializes in helping pharmaceutical, biotechnology and medical device companies obtain timely and comprehensive regulatory approval. With our over eighty employees, our expertise and influence extends from the US market to the Canadian and European markets.

Our goal is to increase our clients’ financial return on investment by offering a comprehensive consulting platform that includes:

  • Strategic planning and general drug development
  • Global scientific regulatory strategies
  • Nonclinical development
  • Clinical development
  • Chemistry, manufacturing and controls (CMC)
  • Current Good Manufacturing Practice (cGMP) management
  • Regulatory Publishing Services (CTD)
  • Training services
  • State Licensing services


505(b)(2) NDA Preparation and Submissions

Beckloff Associates has extensive experience in preparing 505(b)(2) NDAs and successfully submitting these documents to the FDA. Our knowledge and experience with this submission process can reduce the time and effort it takes for the 505(b)(2) preparation, submission and acceptance to the FDA. Beckloff Associates can manage the overall preparation and compilation of the 505(b)(2), as well as direct communication with the agency, allowing our clients to focus their resources on other critical tasks.


IND Preparation and Submission

The Investigational New Drug (IND) application requires knowledge of the scientific and technical process and dedication to detail. Beckloff Associates can aid in preparing a strategy to help navigate through the IND preparation and submission process. BAI can provide continuous support from the early development strategy, technical oversight and review, interactions with the FDA particularly including pre-IND meeting and liaison during the pre-IND discussions.


NDA Preparation and Submission

The NDA preparation explains in great detail the life story of the drug product. Beckloff Associates has technical staff with preclinical/clinical and CMC backgrounds which helps convey appropriate information for the NDA preparation. Our staff will ensure the proper clinical manufacturing and clinical studies data are intact and included in the NDA.


ANDA Preparation and Submissions

ANDA preparation and submissions can be as challenging as a traditional NDA due to the need to not only file information relating to the ANDA itself, but the information of the Registered Listed Drug (RLD) from the original NDA must also be considered. Beckloff Associates has extensive experience with ANDA preparation and submissions with the FDA including discussions to resolve issues in comparing the RLD.


Post-Approval Maintenance Support

Post-approval maintenance requires a large amount of time and removes resources from current pipeline programs. Beckloff Associates’ post-approval maintenance support allows our customers to maintain regulatory and compliance aspects of marketed products without dedicating internal staff. Our post-approval maintenance support allows the customer to have control by using our resource under their direction.


Compliance Audits

Beckloff Associates has conducted numerous manufacturing, testing, and packaging facility compliance audits and have assisted companies in attaining compliance with GMP, GLP, and GCP regulations, which is essential for companies to develop and commercialize products in the United States, Europe, and Canada. Beckloff Associates, Inc. has performed hundreds of global compliance audits for cGMP compliance, PAI readiness, facility GAP analysis, due diligence and directed inspections in API, oral solid, oral liquid, sterile and transdermal product facilities, as well as analytical and microbiological, and GLP laboratories.


Drug Master File (DMF) Preparation and Submission

Beckloff Associates Inc. (BAI) experience with DMF preparation will ensure your documents contain the necessary information for a successful submission for the active pharmaceutical ingredient (API). In addition to preparing this proprietary asset, BAI can also act as your DMF agent in which we will maintain and prepare annual reports as well as any other changes affecting the DMF. BAI can also prepare the Active Substance Master File (ASMF) for European submission and continue the ASMF maintenance. Our publishing group can prepare and submit your DMF to the FDA in paper or electronic (eCTD) format.


eCTD Publishing and eCTD Submissions

Beckloff Associates is an industry leader in the publishing and submission of regulatory dossiers in paper, NeeS and eCTD formats. Our submission experience spans 4 decades, and includes DMF, IND, NDA, ANDA, 505(b)(2), MAA, ASMF, and CTA original submissions. We also prepare labeling in SPL and SPL-PLR formats. Our industrial-strength validated platform for document management and eCTD publishing is ready to provide you with a rapid, investment-free path to eCTD adoption. If you already have or are implementing an eCTD system, we offer training for publishing and scientific teams, as well as throughput assessments and process design services to help drive your return on investment higher.