OTC Pharmaceuticals/Health and Wellness Products
OTC Pharmaceuticals/Health and Wellness Products
At ATL/BV, we understand the rigorous requirements for over-the-counter (OTC) pharmaceuticals and health & wellness products. Consumers expect safe, effective solutions backed by scientific validation, while regulatory agencies enforce strict compliance standards. Whether you’re developing pain relievers, dietary supplements, or topical treatments, our comprehensive testing and formulation services ensure your products meet industry regulations, deliver proven efficacy, and resonate with health-conscious consumers.
Our Expertise in OTC Pharmaceuticals &
Health & Wellness
We specialize in testing and development for a broad range of OTC and wellness products, including:
- Pain Relief and Fever Reducers: Acetaminophen, ibuprofen, aspirin, and combination formulas.
- Cough, Cold, and Allergy Relief: Antihistamines, decongestants, expectorants, and multi-symptom solutions.
- Topical Analgesics & First Aid: Creams, gels, ointments, and sprays for pain relief and wound care.
- Digestive Health Products: Antacids, probiotics, laxatives, and acid reducers.
- Sleep Aids and Stress Support: OTC sleep medications, melatonin, and herbal formulations.
- Vitamins, Minerals, and Dietary Supplements: Multivitamins, functional supplements, and plant-based formulations.
Challenges in the OTC and Health & Wellness Industry
The OTC and wellness market is highly competitive and heavily regulated, with challenges including:
- Regulatory Compliance:
Meeting FDA OTC Monograph requirements, cGMP (Current Good Manufacturing Practices), and global regulatory standards. - Efficacy and Claims Validation:
Substantiating product claims such as “clinically proven,” “fast-acting,” or “24-hour relief.” - Safety and Stability:
Ensuring consistent product quality, bioavailability, and ingredient stability. - Consumer Trust and Transparency:
Addressing clean-label, non-GMO, and organic ingredient demands.
Our scientific and regulatory expertise helps brands successfully navigate these challenges and bring safe, high-quality products to market.
Comprehensive Testing Services for for OTC Pharma &
Health & Wellness Products
Our state-of-the-art testing capabilities ensure scientific validation of performance, safety, and compliance:
- Efficacy Testing:
- Dissolution and disintegration studies for tablets and capsules.
- FDA raw material and finished product testing
- Safety and Toxicology Testing:
- Microbial and preservative efficacy testing for liquid and gel-based formulations.
- Heavy metal, pesticide residue, and contaminant screening for dietary supplements.
- Stability and Shelf-Life Testing:
Long-term and accelerated stability studies per ICH (International Council for Harmonisation) guidelines.
Regulatory and Compliance Support
Our team provides regulatory guidance to ensure seamless compliance and faster market entry:
- FDA OTC Monograph Compliance:
Adhering to established guidelines for active ingredients, labeling, and marketing claims. - cGMP and Quality Control Support:
Helping clients implement quality systems, conduct audits, and maintain documentation to meet FDA and international standards - Claims Validation & Labeling Compliance:
Ensuring claims meet scientific requirements for marketing.
Why Partner with Us?
At ATL/BV, we combine scientific precision with industry expertise to support your product innovation. Whether developing an OTC pharmaceutical or a wellness supplement, we help you:
- Ensure regulatory compliance and safety with rigorous testing.
- Validate product claims with scientific credibility.
- Develop innovative formulations that meet consumer expectations for efficacy and sustainability.
Let’s Advance Health & Wellness Together
Contact us today to learn how our testing and development services can help you bring high-quality OTC and wellness products to market.