RPI Introduces CMC Services

RPI is pleased to introduce our experienced team of Chemistry, Manufacturing and Controls (CMC) experts.

RPI can provide you with comprehensive technical, compliance and writing support services for all of your CMC requirements at all stages of drug and biopharmaceutical development. We have extensive experience in CMO selection and management for small-molecules and biologics for many types of drug substances and all forms of drug products including aseptic fill and finish. Specialty areas include protocol development and reports for the validation of analytical assays, utilities, equipment and processes, OOS investigations, deviation reporting, specification justification stability (including formal stability shelf life projection reports) and development histories. We also offer GMP Quality Assurance and compliance support appropriate to the stage of drug development including SOPs, Test Methods, and facility and laboratory audits and can assist you in preparing for a pre-approval inspection.

Read more about our CMC experts below:

Ramon Burns, Ph.D.
Ramon has over 25 years’ experience in the development, manufacture and control of pharmaceutical products. He started his career at Syntex in parenteral product development and held pharmaceutical and analytical chemistry management positions at Collagen Corporation and Celtrix Pharmaceuticals. Ramon started consulting in 1995 and has worked on a wide variety of projects since involving cost effective, high quality report preparation, data analysis, and scientific or manufacturing process troubleshooting. Ramon is a six-sigma black belt whose technical expertise ranges over assay validation, stability (including formal stability shelf life projection reports), specification justification, and OOS/OOT auditing/root cause analysis. Specialized writing project completed include process descriptions, technology transfer reports, CTD section writing, development history reports, and method comparability reports. Ramon holds a BA degree in Biophysics from the University of Pennsylvania and a PhD in Chemistry from the Massachusetts Institute of Technology.

Robert Lopez
Robert has over 30 years experience in the development, manufacture and registration of biopharmaceuticals. His career started in medical devices and he subsequently held director level positions in a number of biotechnology companies including Genzyme, Genetics Institute, Celtrix and Telik. As a consultant Robert has specialized in CMO project management for biologics and aseptic products, performing activities such as proposals and contracts, budgets, project timelines, SOP and batch record generation and review, batch release, clinical supply logistics, Person in the Plant and on the floor Manufacturing Quality. Robert holds a BS in Medical Microbiology from San Jose State University.

Malcolm McKay, Ph.D.
Malcolm has over 30 years of GXP Compliance and Regulatory Affairs experience in the pharmaceutical industry. He started his career at Abbott Laboratories and later held senior Quality Assurance and Regulatory Affairs positions at a number of small-to-medium companies including Triton Biosciences, Berlex Biosciences, Celtrix Pharmaceuticals, COR Therapeutics, Cell Genesys, InterMune and Vivus. His strategic, tactical and technical experience comes from working with small molecules, peptides and biologics for a variety of dosage forms that involved the successful submission of dozens of CMC dossiers for INDs, BLAs, NDAs and MAAs. Malcolm holds a BS degree in Biology from Portsmouth University and a PhD in Biochemistry from King's College, London.

FDA Draft Guidance on Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications

In July 2014, FDA issued a revised draft guidance for industry titled “Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.” The draft guidance closed for comments on September 23.

Twenty-four months after this guidance document is finalized, the content of certain submission types must be submitted electronically via the Electronic Submissions Gateway (ESG) and formatted according to the eCTD specifications outlined in this guidance.

These requirements apply to all submissions under section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which include submissions under section 505(b) (new drug), 505(i) (clinical trial), or 505(j) (generic drug) of the FD&C Act, and under section 351(a) (biologic) or 351(k) (biosimilar) of the Public Health Service Act (PHS Act). These include:

• Certain INDs;
• NDAs;
• ANDAs; and
• Certain BLAs. 

Submissions that are not submitted electronically and electronic submissions that are not in the format specified in this guidance document will not be filed, unless exempted from the electronic submission requirement. FDA will exempt the following types of submissions:

• All submissions regarding devices that are regulated by CBER as biological products under section 351 of the PHS Act;
• Noncommercial INDs; and
• Existing master files previously submitted in non-electronic format.

This draft guidance is a revision of the draft guidance previously issued in January 2013. When finalized, it will supersede the guidance issued in June 2008 titled “Providing Regulatory Submissions in Electronic Format — Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.”

Contact RPI for assistance in meeting FDA’s new electronic submission requirements.

EU Clinical Trials Regulation

On May 27, 2014, the Clinical Trials Regulation was published in the Official Journal of the EU (OJEU). It will replace the existing EU Clinical Trials Directive and streamline the authorization process. The legal form of a Regulation ensures that EU Member States, in authorizing and supervising the conduct of a clinical trial, do so on the basis of identical rules. Barring IT issues, it will apply starting from May 28, 2016.

The key provisions include:

• Applicants will submit a single application for the authorization of a clinical trial via a single EU portal. Applications will receive a single assessment outcome, regardless of the number of EU Member States concerned.
• The European Commission will have the possibility to conduct controls in EU countries and third countries to make sure rules are being properly supervised and enforced.
• Certain clinical trials determined to be “low-intervention,” such as those comparing already authorized medicines, will be subjected to lighter regulatory requirements.
• Clinical trials conducted outside the EU but referred to in a clinical trial application within the EU must comply with regulatory requirements at least equivalent to those in the EU, including rules on transparency.
• Member States will have the possibility to stop any clinical trial which they consider could endanger the heath of the participants.

For further assistance with the EU clinical trial authorization process, contact RPI.