Our Services
-
Auditing
Our team includes seasoned auditors with expertise in a wide range of GxP disciplines, encompassing GMP, GPVP, GCP, GLP and even GTP.
See additional details below
-
Remediation
Realize lasting improvements from experts who have seen it all.
See additional details below
-
Education & Training
Whether it's through our pre-existing interactive training courses or tailored, customized courses, we can assist our clients in enhancing their knowledge in specific areas of interest.
See additional details below
-
Project Management
Be it for long-term or short-term project management, we have experienced personnel capable of ensuring smooth operations and bringing order to what may seem chaotic.
See additional details below
Detailed Services
Auditing
We have a wealth of experience conducting audits in various GxP disciplines (GMP, GCP, PV, GLP, GTP) for products destined for global markets. These audits encompass the following types:
Mock PAI / Pre-approval inspection preparation
Directed Investigations
Periodic Maintenance Audits to prepare for Regulatory authority audits
Sterile Drug Product or Drug Substance
APIs, Excipients, Food grade
Solid Oral Dosage
Nutritional Supplements
Liquids, Oil, Creams
Patch formulations
Biologics
Medical Device / Combination Products
CSV / SaaS
Software as a Medical Device
Remediation & Review
The process of remediation can be challenging and time-consuming. Allow us to lead you through it and aid in implementing enduring solutions to prevent future issues. For example we can provide:
Reviewing, discussing, and aligning on responses (483, warning letters) to Regulatory Authorities
Comprehending the various levels of FDA action alerts (i.e. OAI, VAI), what to anticipate, and how to address them
Counsel on how to align with FDA expectations based on their procedures and internal structure
Working jointly with clients to rectify FDA-identified concerns and implement sustainable solutions
Preparing and assisting in FDA meetings
Reviewing and tracking CAPA responses
For general GxP advice regarding quality-related queries, consult our experts for expert guidance.
Project Management
Whether it's design and development, clinical phases from I to III, or post-market surveillance and pharmacovigilance, our experienced project managers can assist you at every step. For instance:
Quality Management System development for those starting up or entering a new product area
Program support and / or Protocol development for Validation / Qualification
Protocol development DQ, IQ, OQ, PQ
Protocol development Process or Software Validation
Auditor certification program development
Investigation / CAPA / Nonconformance support
Inspection readiness across sites
ANDA and NDA compliance reviews
Enhancement to current Quality Systems and Regulatory Compliance activities for continuous improvement goals. This can be based on our own assessment, internal assessments, or other third party assessments
Education & Training
We have developed interactive courses that can be delivered on-site or virtually. We provide both customized courses tailored to a client’s specific needs, or pre-defined courses such as the following:
Integrity / GMP Integrity for the Pharmaceutical Industry (How to “Think” like an FDA Investigator”)
OOS and Compliant Investigations (How to investigate and write an effective investigation that will hold up in inspection)
Aseptic Techniques (What are they, and how to execute them)
Auditor Development (How to be an auditor and build those skills)
Preparing for an FDA Inspection
Additional Services
and information
FDA Meeting Support
-
We offer valuable insights into what to anticipate during an FDA meeting and how to effectively propose such meetings. In addition to meeting preparation, we provide mock meeting dry runs to help clients become more at ease and confident when the actual meeting takes place.
-
Our team is capable of attending FDA meetings alongside our clients to provide guidance on effective responses and strategies. With our experts having years of experience working within the FDA, we offer invaluable insights and support throughout the meeting process.
DEA Audits
-
We can aid you in preparing for an inspection with a thorough review of your processes and record-keeping for DEA (Drug Enforcement Administration) controlled substances.
-
Enhance your comprehension and gain practical experience in the security regulations governing DEA-controlled substances.
-
Support in deciphering the "Know Your Customer Policy," which is a mandatory requirement for DEA-registered Manufacturers and Distributors dealing with controlled substances in Schedules I through V and regulated chemical products.
Staff Augmentation
-
Require additional assistance?
Our subject matter experts (SMEs) are available to provide support in various quality system areas across different disciplines.
-
We can assist you in the management of your annual FDA registrations. Our team not only possesses in-depth knowledge of the registration process but also brings project management expertise to ensure the timely renewal of your registrations.
-
Internal audits are obligatory for pharmaceutical companies and can be a time-consuming process when it comes to creating the necessary procedures, policies, and assembling a certified auditing team. We offer regular maintenance audits conducted with an impartial perspective. Our annual plans encompass the essential audits you require, and we can also assist in establishing the procedures and processes necessary to manage your audit program.
Take a minute to Download our Brochure of Services and fill out the form below
Let’s work together.
Interested in working together? Fill out some info and we will be in touch shortly! We can't wait to hear from you!