Device Regulatory Affairs

The regulatory services provided to our clients (sponsors of medical devices) span a broad range of diagnostic and therapeutic specialties.  Our capabilities include developing regulatory strategies for successful submissions, preparing plans for FDA interactions and resource planning.  We can prepare an entire regulatory submission, individual sections of a submission, or simply review the submission the sponsor has prepared.

Our services include:

Ø      Strategic regulatory consulting and planning, including:

·      Development of preclinical and clinical trial design

·      Medical device classification

·      Submission classification for products with combined regulatory status

·      Interpretation of legislation, regulations, and guidelines, including import and export applications

·      Regulatory review of advertising and promotional material

·      Due diligence and consultation with venture communities and law firms on acquisition and compliance issues

·      Guidance on access to investigational devices during regulatory application preparation and review

Ø      FDA Submission: Complete or partial submission management, preparation and evaluation (E.G., IDEs, 510(k)s, PMAs, Supplements, Updates, Amendments, Petitions, etc.).

Ø      FDA Representation: Preparation and coordination of meetings with regulatory authorities including “relationship” guidance and panel meetings.

Ø      Post-market surveillance program evaluation and guidance, including post-approval studies, safety issues and alerts, and labeling review.

Ø      Humanitarian Device Exemption guidance and assistance.

Statistical Services

The Statistical Services group provides statistical support for device and biologic products.  Our statisticians, former FDA and industry professionals have decades of experience in a wide range of therapeutic areas.  We can provide full service from a study design to final report and representation or provide services on a consultancy basis.  However, when our services are utilized, our senior-level staff is directly involved and the client benefits from their expertise.

Statistical services include:

Ø      Preparation of responses to FDA inquiries regarding statistical issues or deficiencies

Ø      Preparation and coordination of meetings with regulatory authorities

Ø      Assistance in protocol development, including refinement of research questions, study design, sample size justification, and description of statistical analysis methods

Ø      Assistance with product development strategies to optimize likelihood of regulatory approval

Ø      Pre-clinical and clinical study design and analysis

Ø      Statistical analysis, programming and reports

Ø      Product applications and guidelines

Ø      FDA relationship guidance and dispute resolution

Ø      Performance of interim analysis for regulatory authorities and Data Safety Monitoring Boards

Ø      Comprehensive final data analysis and report suitable for inclusion in regulatory applications, submissions, presentation and publication

Ø      Support for preparation of regulatory and submissions

Ø      Computerized patient randomization

Ø      Design, analysis and interpretation of experimental pre-clinical studies

Ø      Design of experiments for manufacturing in-process, end-stage quality control, and product development and evaluation

Quality Systems & Compliance

R.P. Chiacchierini & Associates, with support from affiliated consultants, offers numerous services relating to quality systems and compliance for medical devices and biologic products.  These services include:

Quality Systems:

¨      The design, development and implementation of complete or partial quality systems that satisfy FDA, ISO 9000 and EN 46000 requirements, including Standard Operation Procedures, QA manuals and clinical trial systems, Design control systems, corrective action systems and product compliant reporting systems.

¨      CE Mark preparation and submissions

¨      Verification and validation assessments

¨      Process validation review and assistance

¨      Statistical process control

¨      Internal Quality Systems Audits

¨      Due diligence audits for suppliers, potential suppliers, acquisitions and CROs

¨      Pharmaceutical and device facility design, including controlled environments for sterile and non-sterile products

Compliance:

¨      Audits of clinical data contained in regulatory submissions

¨      Quality assurance of internal operations, trial protocols/case report forms, sponsor to agency study reports and submissions, protocol implementation at trial sites and IRBs

¨      FDA compliance management, including FDA 483s, warning letters, consent decrees and recall strategies

¨      Assessment and preparation for regulatory inspections

¨      Assistance with agency representation and negotiation

Biologics Regulatory Services

R. P. Chiacchierini & Associates, with support from affiliated consultants, provides a broad range of regulatory and clinical consulting services to companies who are involved with or manufacture biologic products.

These services include:

¨      Strategic product development and regulatory planning

¨      Product development guidance

-     Blood and blood products

-     Blood banking and transfusion services

-     Infectious disease diagnostic test kits (e.g., serologic, NAT, markers, etc.)

-     Computer driven testing devices

-     Biologic devices and biologic/device combinations

-     Blood bank stand alone software

¨      Protocol development and implementation

¨      Study monitoring and auditing

¨      Regulatory submissions [IND, ELA/PLA, BLA, IDE, PMA, and 510(k)]

-      Strategy development and implementation

-      Document and submission preparation

-      FDA meeting coordination, preparation and assistance

¨      Facility evaluation for the production of biologic products

¨      Due diligence and consultation with the venture funding communities and law firms on acquisition, licensing, and compliance issues