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Regulatory Affairs
Pre-IND regulatory consulting services through NDA

Pre-IND / Pre-IDE regulatory consulting services through NDA / PMA approval, the level of regulatory FDA consulting & guidance Synergy Research provides stands well above the rest.  Our overwhelming success in bringing difficult development programs to fruition is the hallmark of our repeat business partnerships.  

Careful consideration is given to each product development program in order to assure for proper placement in the minds of regulators, while never compromising the positioning of the product itself.  Oftentimes sacrifices are made with respect to drug and device development plans in order to accommodate regulatory or geo-logistical considerations.  We at Synergy don't believe in compromising product life cycles and patent positions for the sake of legislation.  Rather, creative brainstorming allows for most if not all situations to be turned to WIN-WIN and successful development strategies.



Regulatory Services Offered


Nonclinical Regulatory Services are typically provided as part of comprehensive CRO drug development service programs designed for our sponsor clients.  We also offer this service on a standalone basis.  In a typical team approach we include extensive experience in regulatory, pharmacology, and toxicology.  Our team can work as an extension of your team, or contract out to us your entire nonclinical development program.


Pre-IND and Pre-IDE Meeting Programs. Synergy Research takes Early Collaboration Meetings  extremely seriously.  The rules are clear on early collaboration type meetings.  These meetings fall under the Type B category of Guidance: Formal Meetings With Sponsors.  Too often we are doing damage control on programs that haven't been fully vetted or fleshed out through to expected resulting feedback from FDA.  Not only for the immediate need on a pre-submission package, but on the development strategy and program from a broader sense.  Most if not at all times, a sponsor has, at best, a single opportunity to obtain an early collaboration meeting.  It is quite common these days, post 2008, that FDA declines early collaboration meetings (special considerations being made for Subpart E programs).


Most common errors made by regulatory staff when submitting briefing packages to FDA for early collaboration meetings:


  • global, pie-in-the-sky type questions, that the FDA cannot and will not answer

  • what-if scenarios, that have no place in a briefing package of this nature

  • overburdening the FDA with volumes of information, that they will not read, unless given a clear reason to

  • leaving out supportive data / documentation for those questions that are sound, but require evidence, keep in mind, the FDA is an empirically driven organization

  • ALWAYS avoid the temptation to make an opening presentation, simply reading to the FDA what is already in the briefing package.  If it isn't in the briefing package to begin with, consider why you plan on surprising the FDA with new data, and how they will react to such.  If it means rescheduling the meeting, give that some serious consideration, rather than offering surprise data, and not getting spontaneous FDA feedback, which would not be the norm.  Again, keep in mind, the FDA is an empirically driven organization


Synergy Research manages several Early Collaboration Meetings on an annual basis.  We assemble a team best geared for your program, from in-house and contract experts.  We can integrate with your staff and program, or provide a turnkey solution.  We work with our own network of current and past FDA staff, to provide our clients an intelligent well thought out regulatory strategy.  You can verify our results with countless satisfied clients.  For original as well as salvaged programs from other consultants or service providers.


IND Submissions. Synergy Research provides comprehensive IND preparation and submission programs.  We can integrate with your nonclinical, clinical, CMC staff or consultants, or provide a turnkey program.  We build an IND electronically, on an Adobe PDF share portal.  Sponsor participants can access the portal, view documents, and provide feedback on an ongoing basis.  When completed, our Adobe portal archives, distributes, even does sequential IND numbering for the client.  Bound copies are distributed as requested.  This program makes for an easy international IND development effort.


505(b)(2) Strategy, Programs, & Submissions. Synergy Research has been conducting 505(b)(2) drug programs for many years.  We help firms identify potential candidates for 505(b)(2), assist in evaluating the process needed to obtain FDA input regarding the appropriateness of a 505(b)(2) development program, assist firms in evaluating the benefits available via the 505(b)(2) route.  In recent years drug approval rates for 505(b)(2) programs have increased dramatically, surpassing 505(b)(1) approvals.  The key to undertaking 505(b)(2) development programs is to build a strategy, and understand the various options and outcomes of these programs when properly designed.  It is important to approach the FDA with a well thought out 505(b)(2) strategy, including supporting evidence to justify the clinical development plan.


What to AVOID in 505(b)(2) programs:  The pIND program should be considered a luxury to pharmaceutical firms.  You have a chance to meet the FDA and obtain formal written feedback and commitments to your drug development program.  It is the rule of thumb that you only get one chance for this pIND meeting.  Unfortunately, we have seen too often, young and inexperienced firms approach the FDA with hypothetical questions.  Questions such as "what if" this, and "what if" that.  It is difficult, if not impossible for FDA to give solid advice and commitment to "what if".  Overly broad questions, which just cannot elucidate a reasonable answer have no place in a pIND.  Asking a question where no supporting data are provided is another frequent trap in this process.  Avoid the pitfalls of losing your one pIND opportunity. Build a solid pIND program and package.  Be smart about the questions posed to the FDA.  Give them what they need in order to answer the questions that MATTER to a pharmaceutical firm.


Generic Pharmaceuticals. Synergy Research offers the full range of expertise, from clinical programs in support of ANDAs, to regulatory filings on generic drugs.  Assistance in procurement of reference drug product.  Locating DMF, sources for active ingredients, excipients.  Preparation of DMFs. cGMP audits.  Consulting on validation and analytical support services.  Conducting bioequivalence studies acceptable to FDA.  Non-clinical / clinical summaries.  Serve as Regulatory Agent in US.  Extensive experience in 505(b)(2) programs.  Design pre-IND strategies for 505(b)(2) products, prepare briefing packages for Type B meetings / Generics, represent sponsor at pre-IND meetings, coordinate team review and rehearsal meetings.  The regulatory process for generics in the US can be difficult and confusing.  Sponsor companies need focused detailed guidance to navigate these waters, to avoid delays in time and monies.  Synergy collects the resources required, to integrate with the sponsor resources, creating a single team, focused on getting each candidate approved.

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